CBR ENTERPRISE LIMITED

FDA Device Registration & Listing · Hong Kong, HK · Registration 3013557562

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013557562
FEI Number
3013557562
Entity Name
CBR ENTERPRISE LIMITED
City/State/Country
Hong Kong, HK
Establishment Address
300 Des Voeux Road Central, Suite A, 9/F., Wah Kit Commercial Centre, Hong Kong Hong Kong, HK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
CBR Enterprise Limited (Owner Number: 10054430)
Owner / Operator Contact Address
300 Des Voeux Road Central, Suite A, 9/F., Wah Kit Commercial Centre, Hong Kong, HK-NOTA Hong Kong, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K880733
PMA Number
N/A

All Registered Proprietary Names

Tubes, vials, systems, serum separators, blood collection BAG, URINE COLLECTION, LEG, Needle Drape POST, ROOT CANAL Needle FORCEPS, BIOPSY, ELECTRIC Device, specimen collection NEEDLE BC 21X1.25 ECL Stethoscope Electrosurgical, cutting & coagulation & accessories PROTECTOR, OSTOMY APPLICATOR FORCEPS, BIOPSY, NON-ELECTRIC Device, monitoring, intracranial pressure Shunt, central nervous system and components CURETTE, SUCTION, ENDOMETRIAL Insufflator, hysteroscopic Thermometer, electronic, clinical INSTRUMENT, ENT MANUAL SURGICAL Indicator, physical/chemical sterilization process COLLECTOR, OSTOMY HUMIDIFIER, RESPIRATORY GAS Tubes, vials, systems, serum separators, blood collection Syringe, piston HYSTEROSCOPE BLOOD TRANSFER AND LUER LOCK ACCES Oximeter, ear SOLUTION SET, CLEARLINK BURETROL CONTAINER, SPECIMEN, STERILE INSTRUMENTS, DENTAL HAND ENDOSCOPE Cleaner, ultrasonic, medical instrument VENTILATOR Instrument, ultrasonic surgical Tubes MBO-INDICATOR,CHEMICAL,TROPHON COVER,PROBE,CLEAN,TROPHON Catheter dc-defibrillator, Oximeter CONTAINER, LIQUID MEDICATION, GRADUATED Bandage, liquid, skin protectant STOPCOCK MANIFOLD 3 GANG LARGE BORE SPECULUM Polymer patient examination glove Irrigator, ostomy negative pressure wound therapy Powered suction pump PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Set, administration, intravascular Tube tracheostomy and tube cuff Tampon, menstrual, unscented Tubes, vials, systems, serum separators, blood collection DRILL, DENTAL, INTRAORAL intravascular SPIROMETER, MONITORING Catheter Tubes Oximeter COVER, CAST CONNECTOR, AIRWAY Syringe, piston Syringe Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2022-10-25
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus Microbiology Class 1 866.3480 2023-12-18
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-07-29
LJE Catheter, Nephrostomy Unknown Class U N/A 2023-06-28
KOB Catheter, Suprapubic (And Accessories) Gastroenterology, Urology Class 2 876.5090 2023-06-28
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-05-25
LXZ Guard, Instrument General, Plastic Surgery Class 1 878.4800 2023-06-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-09-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-07-08
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2022-12-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-12-07
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2022-06-16
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2017-04-03
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2022-01-10
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2024-05-20
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2019-07-16
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus Microbiology Class 1 866.3480 2023-11-20
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2024-10-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2017-04-03
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2024-07-09
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2021-09-03
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2020-01-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-03-05
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2023-04-04
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2024-08-26
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2024-08-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-11-22
ELR Post, Root Canal Dental Class 1 872.3810 2021-12-16
MMK Container, Sharps General Hospital Class 2 880.5570 2025-01-28
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2022-03-24
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2024-03-28
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-10-17
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2022-12-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2018-04-26
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2021-09-03
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-03-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-01-25
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-11-20
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2018-02-22
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2022-07-01
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-06-21
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2018-04-16
BRZ Set, Blood Transfusion General Hospital Class 2 880.5440 2020-06-24
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2023-03-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-09-28
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2026-06-18
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2024-02-19
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2023-05-19
FMR Device, Transfer, Patient, Manual General Hospital Class 1 880.6785 2019-12-31
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2017-10-25
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2026-06-05
LYG Massager, Therapeutic, Manual Physical Medicine Class 1 890.5660 2024-07-01
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2024-03-28
LIO Device, Specimen Collection Microbiology Class 1 866.2900 2017-12-28
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2017-04-25
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-01-04
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2023-03-24
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2021-04-19
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2024-01-17
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2025-02-11
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2017-05-26
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-02-01
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2026-05-06
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2020-04-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-06-24
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2023-06-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-08-16
NEP System/Device, Pharmacy Compounding General Hospital Class 2 880.5440 2024-04-10
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2024-04-10
KPE Container, I.V. General Hospital Class 2 880.5025 2021-08-13
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2024-05-15
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2020-12-16
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2023-01-16
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-01-16
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2019-06-24
DQA Oximeter Cardiovascular Class 2 870.2700 2023-05-19
ITM Cage, Knee Physical Medicine Class 1 890.3475 2018-10-24
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2020-04-14
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-01-16
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2025-11-17
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2022-12-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-03-21
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2023-05-11
NEP System/Device, Pharmacy Compounding General Hospital Class 2 880.5440 2023-09-28
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2017-05-26
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2023-11-24
MEG Syringe, Antistick General Hospital Class 2 880.5860 2020-05-22
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2023-06-27
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-05-24
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-05-30
EXE Protector, Ostomy Gastroenterology, Urology Class 1 876.5900 2021-09-20
LRD Applicator, Ent Drug Ear, Nose, Throat Class 1 874.5220 2021-10-11
HRX Arthroscope Orthopedic Class 2 888.1100 2023-10-18
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2023-08-17
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2017-04-03
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2018-02-22
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2022-12-05
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2023-03-14
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2024-05-20
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2018-01-19
NFB Conserver, Oxygen Anesthesiology Class 2 868.5905 2025-04-04
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2018-11-12
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2024-08-08
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2023-07-13
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2025-03-31
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2024-07-09
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2024-01-11
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2024-01-11
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2023-07-18
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-11-17
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2020-03-03
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-08-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-01-24
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2023-06-29
IPW Orthosis, Sacroiliac, Soft Physical Medicine Class 1 890.3490 2019-08-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-12-21
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-11-27
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2020-02-07
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2023-08-22
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-01-23
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2023-11-20
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2023-11-20
JEQ Toothbrush, Powered Dental Class 1 872.6865 2024-07-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-01-24
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2024-01-17
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2023-09-20
KPE Container, I.V. General Hospital Class 2 880.5025 2023-12-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-05-15
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2017-09-12
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2023-12-11
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2018-11-27
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2020-03-31
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2018-02-22
HHI System, Abortion, Vacuum Obstetrics/Gynecology Class 2 884.5070 2018-02-22
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-01-08
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2018-09-21
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2021-08-23
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2022-12-05
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2019-07-03
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2018-02-22
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-08-28
HFW Clamp, Umbilical Obstetrics/Gynecology Class 2 884.4530 2023-06-26
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2018-02-22
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2023-03-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-07-01
EWO Audiometer Ear, Nose, Throat Class 2 874.1050 2024-01-23
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-05-24
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2025-05-08
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2017-10-30
JEQ Toothbrush, Powered Dental Class 1 872.6865 2023-06-09
DQA Oximeter Cardiovascular Class 2 870.2700 2024-11-21
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2021-10-08
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2024-04-10
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2017-05-26
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2023-10-10
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2022-12-01
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2023-05-25
HRX Arthroscope Orthopedic Class 2 888.1100 2020-07-14
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2020-07-14
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-05-15
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2024-12-03
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-05-22
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2025-07-09
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-04-25
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2024-08-19
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2023-12-15
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2017-10-30
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-06-23
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2025-02-11
FOC Bag, Urine Collection, Newborn Gastroenterology, Urology Class 2 876.5250 2023-06-26
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 2020-08-14
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-01-28
JTW System, Transport, Aerobic Microbiology Class 1 866.2900 2023-07-05
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-10-25
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2018-05-09
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2023-08-16
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2017-09-13
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2017-09-13
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2017-10-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-05-05
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-02-21
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-02-21
MEG Syringe, Antistick General Hospital Class 2 880.5860 2024-02-21
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2018-04-25
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-05-15
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-05-08
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2023-10-26
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2021-03-03
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2021-08-12
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2021-11-12
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2022-10-12
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2025-03-31
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2022-05-19
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2024-03-21
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2017-10-31
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2024-07-05
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-05-24
FMF Syringe, Piston General Hospital Class 2 880.5860 2017-12-11
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2017-04-25
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2018-02-22
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-02-22
HLI Ophthalmoscope, Ac-Powered Ophthalmic Class 2 886.1570 2017-11-16
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2019-07-26
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2023-10-18
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2022-11-22
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2026-04-30
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2021-12-08
NTW System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test Immunology Class 2 866.4070 2026-01-19
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2021-04-27
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-07-14
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2022-05-19
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-12-10
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-12-10
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2023-09-11
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2022-05-05
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2023-05-28
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2023-05-28
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-05-28
JRL Unit, Filter, Membrane Clinical Chemistry Class 1 862.2050 2024-07-09
DQA Oximeter Cardiovascular Class 2 870.2700 2025-03-11
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2022-09-29
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2021-08-23
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-05-03
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2023-09-20
FNY Basin, Emesis General Hospital Class 1 880.6730 2026-04-30
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2019-07-08
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2023-01-16
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2024-10-30
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2025-03-28
EFW Toothbrush, Manual Dental Class 1 872.6855 2019-10-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2021-01-19
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-06-27
DZN Instruments, Dental Hand Dental Class 1 872.4565 2021-11-12
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2023-10-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-09-09
DQA Oximeter Cardiovascular Class 2 870.2700 2019-09-09
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-09-09
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2017-10-31
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-09-28
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2023-05-24
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-06-06
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-04-11
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2021-12-28
IWZ Film, Radiographic Radiology Class 1 892.1840 2022-03-10
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2022-06-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-06-03
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2024-01-25
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-01-25
EZC Catheter, Coude Gastroenterology, Urology Class 2 876.5130 2023-01-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-05-05
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2025-02-24
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2018-11-12
GCI Laryngoscope, Endoscope Gastroenterology, Urology Class 2 876.1500 2022-03-25
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 2018-11-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-07-14
GBO Catheter, Nephrostomy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2023-05-11
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-05-11
LJE Catheter, Nephrostomy Unknown Class U N/A 2023-05-11
FQH Lavage, Jet General Hospital Class 2 880.5475 2024-01-29
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-03-21
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-02-02
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-05-11
MND Ligator, Esophageal Gastroenterology, Urology Class 2 876.4400 2023-05-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-08-05
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2025-08-05
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2021-10-08
FQM Bandage, Elastic General Hospital Class 1 880.5075 2017-10-17
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-06-20
DQA Oximeter Cardiovascular Class 2 870.2700 2023-05-16
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2020-06-17
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2019-10-11
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2020-03-31
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2025-03-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-12-30
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2020-10-14
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2024-04-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-04-08
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2024-01-04
DQA Oximeter Cardiovascular Class 2 870.2700 2024-01-04
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2018-02-22
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2021-10-11
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2018-02-21
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2026-04-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-18
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2025-06-23
FFF Cover, Biopsy Forceps Gastroenterology, Urology Class 1 876.1075 2026-05-15
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-07-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-06-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-01-03
DQA Oximeter Cardiovascular Class 2 870.2700 2020-07-08
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2023-08-18
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2018-11-28
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2020-12-17
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2023-07-20
HAM Apparatus, Electrosurgical General, Plastic Surgery Class 2 878.4400 2022-07-01
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2025-06-06
EJJ Alloy, Amalgam Dental Class 2 872.3070 2024-01-29
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2018-02-07
MEG Syringe, Antistick General Hospital Class 2 880.5860 2023-01-24
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-03-31
EZR Cement, Stomal Appliance, Ostomy Gastroenterology, Urology Class 1 876.5900 2022-11-04
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2024-07-09
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2024-10-14
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2026-04-27
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2026-02-20
DQA Oximeter Cardiovascular Class 2 870.2700 2020-11-30
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2019-06-18
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2023-05-05
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2023-04-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-08-10
JES Floss, Dental Dental Class 1 872.6390 2026-05-26
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2022-07-01
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-07-01
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-07-14
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-05-05
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-07-12
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2022-11-03
KCN Ear Wick Ear, Nose, Throat Class 1 874.5220 2018-04-18
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2022-05-24
MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Microbiology Class 2 866.3169 2018-08-24
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-05-11
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2018-06-13
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2023-03-24
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2023-06-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-06-23
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2021-12-08
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2018-10-24
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2026-02-16
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2022-07-14
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2021-10-26
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2017-03-22
HDX Dilator, Vaginal Obstetrics/Gynecology Class 2 884.3900 2017-05-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-07-01
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2022-07-01
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2020-03-31
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2023-12-15
MMK Container, Sharps General Hospital Class 2 880.5570 2025-03-31
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2019-08-27
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2020-08-04
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2023-05-24
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2024-05-20
PJE Blood/Plasma Collection Device For Dna Testing Clinical Chemistry Class 2 862.1675 2022-06-24
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2017-12-11
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2024-02-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-08-12
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2024-01-18
BSF Absorber, Carbon-Dioxide Anesthesiology Class 1 868.5310 2019-02-21
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-07-01
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2022-07-01
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2024-12-09
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2019-12-31
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-12-09
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-06-24
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2017-05-26
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2024-03-28
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-09-01
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2022-03-24
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2022-03-24
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2019-01-30
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2019-07-03
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2020-05-13
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2020-05-13
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2020-05-13
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2020-05-13
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2020-05-13
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2020-05-13
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2020-05-13
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2020-05-13
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2020-05-13
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2020-05-13
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2024-01-31
LIX Aid, Cardiopulmonary Resuscitation Cardiovascular Class 2 870.5210 2024-01-31
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-05-11
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2018-06-21
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2018-09-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-09-06
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2025-07-16
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2020-02-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-08-02
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2021-08-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2023-02-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-06-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-06-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-05-05
MEG Syringe, Antistick General Hospital Class 2 880.5860 2021-11-05
FMF Syringe, Piston General Hospital Class 2 880.5860 2021-11-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-11-22
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-11-10
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2017-03-22
DWH Blade, Saw, Surgical, Cardiovascular General, Plastic Surgery Class 1 878.4820 2025-03-20
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2017-10-30
EXD Irrigator, Ostomy Gastroenterology, Urology Class 2 876.5895 2021-09-20
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2020-12-07
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2017-05-26
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2022-03-24
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2018-07-06
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-12-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-12-03
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2024-11-14
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2026-05-20
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-02-26
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-07-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-03-03
QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection General, Plastic Surgery Class 2 878.4040 2025-02-19
BWC Needle, Emergency Airway Anesthesiology Class 2 868.5090 2023-09-14
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2023-09-14
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2018-04-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-01-23
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2017-04-03
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2022-07-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-07-01
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2022-09-19
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2026-05-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-05-14
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-12-07
KMF Bandage, Liquid General Hospital Class 1 880.5090 2024-08-26
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2024-04-08
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2021-10-20
BSB Warmer, Blood, Non-Electromagnetic Radiation Hematology Class 2 864.9205 2023-07-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-07-26
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2023-07-13
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2023-07-13
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2023-06-01
FSA Lift, Patient, Non-Ac-Powered General Hospital Class 1 880.5510 2018-05-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2017-10-16
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2021-03-30
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-04-25
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2023-05-11
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-12-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-02
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-12-03
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2024-12-03
GXZ Electrode, Needle Neurology Class 2 882.1350 2024-12-03
IKX Aid, Transfer Physical Medicine Class 1 890.5050 2020-10-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-10-14
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2020-11-16
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-09-20
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2022-01-07
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2017-04-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-02-05
BWF Spirometer, Therapeutic (Incentive) Anesthesiology Class 2 868.5690 2023-09-28
FHX Jelly, Lubricating, For Transurethral Surgical Instrument Gastroenterology, Urology Class 2 876.1500 2023-11-20
KMF Bandage, Liquid General Hospital Class 1 880.5090 2020-04-02
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2018-03-15
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2020-04-23
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2026-02-20
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-07-23
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2024-07-23
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-09-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-05-04
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2019-07-10
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2022-09-06
KYR Bag, Ice General Hospital Class 1 880.6050 2023-10-25
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2021-12-16
KMF Bandage, Liquid General Hospital Class 1 880.5090 2019-04-17
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2021-12-17
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2021-11-11
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2017-05-26
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-06-23
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2019-02-21
MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry Class 1 862.1113 2020-09-04
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2022-12-30
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2017-10-25
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2018-03-19
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-13
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-11-15
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2023-11-15
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2025-11-25
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2023-10-10
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-12-11
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2019-12-31
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-07-03
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2025-11-17
PTI Non-Coring (Huber) Needle General Hospital Class 2 880.5570 2025-01-27
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-12-13
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2019-07-10
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-05-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-11-13
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-11-13
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-11-13
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-06-23
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2025-07-24
FRN Pump, Infusion General Hospital Class 2 880.5725 2023-12-29
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2023-11-30
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2017-10-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-18
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2022-05-26
DSF Recorder, Paper Chart Cardiovascular Class 1 870.2810 2019-09-09
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-12-18
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2026-05-27
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2026-05-27
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2026-05-27
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2026-05-27
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2026-05-27
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2026-05-27
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2026-05-27
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2026-05-27
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2026-05-27
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2026-05-27
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2026-05-27
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-05-11
MEG Syringe, Antistick General Hospital Class 2 880.5860 2023-01-25
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2021-10-19
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2024-04-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-12-05
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2023-06-23
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-03-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-04-01
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2017-03-22
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2022-10-20
FFY Adaptor, Bulbs, Miscellaneous, For Endoscope Gastroenterology, Urology Class 1 876.1500 2025-12-10
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2023-05-05
GXZ Electrode, Needle Neurology Class 2 882.1350 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-02-09
EFH Paper, Articulation Dental Class 1 872.6140 2017-10-25
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2017-03-22
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2022-05-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-12-05
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2021-10-07
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2023-08-17
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2023-08-17
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-08-17
JES Floss, Dental Dental Class 1 872.6390 2019-11-12
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2024-02-16
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-05-14
DQA Oximeter Cardiovascular Class 2 870.2700 2021-06-29
DRC Trocar Cardiovascular Class 2 870.1390 2025-03-03
KIA Cover, Cast General Hospital Class 1 880.6185 2021-06-25
JEQ Toothbrush, Powered Dental Class 1 872.6865 2019-05-02
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2022-03-09
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2017-12-11
JEQ Toothbrush, Powered Dental Class 1 872.6865 2023-06-09
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2021-09-20
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-04-25
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-01-23
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2023-06-26
KZD Infusor, Pressure, For I.V. Bags General Hospital Class 1 880.5420 2026-02-13
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-05-11
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2017-05-09
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2017-05-09
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2017-05-09
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2017-05-09
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2017-05-09
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2017-05-09
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2017-05-09
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2017-05-09
JEQ Toothbrush, Powered Dental Class 1 872.6865 2026-02-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-06-24
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2025-02-05
FSH Tray, Surgical, Needle General, Plastic Surgery Class 1 878.4800 2025-02-05
BTL Ventilator, Emergency, Powered (Resuscitator) Anesthesiology Class 2 868.5925 2018-08-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-11-03
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2022-01-07
DQA Oximeter Cardiovascular Class 2 870.2700 2023-10-26
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2023-05-05
HGE Amniotome Obstetrics/Gynecology Class 1 884.4530 2026-04-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-09-01
FMF Syringe, Piston General Hospital Class 2 880.5860 2018-11-12
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2023-09-05
HNY Cystotome Ophthalmic Class 1 886.4350 2020-03-31
FMF Syringe, Piston General Hospital Class 2 880.5860 2021-04-28
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2020-07-24
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2024-05-03
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2023-07-24
KDT Container, Specimen Mailer And Storage, Sterile Pathology Class 1 864.3250 2023-01-04
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-07-01
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2022-05-26
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2020-04-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-05-05
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-07-18
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2019-07-10
EXH Bag, Urinary, Ileostomy Gastroenterology, Urology Class 1 876.5900 2025-06-19
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2024-05-01
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2025-05-08
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-01-16
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-03-08
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2022-10-28
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2023-11-15
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-07-06
GFD Dermatome General, Plastic Surgery Class 1 878.4820 2025-01-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-09-19
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-04-08
KMF Bandage, Liquid General Hospital Class 1 880.5090 2024-05-03
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2019-07-15
HLI Ophthalmoscope, Ac-Powered Ophthalmic Class 2 886.1570 2019-07-15
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2023-05-19
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2017-06-27
NRU Chair, Dental, Without Operative Unit Dental Class 1 872.6250 2025-05-08
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2026-06-05
FAM Sigmoidoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2019-06-18
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-07-14
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2017-12-11
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2026-06-12
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2026-06-12
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-05-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-06-26
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-06-26
FER Anoscope And Accessories Gastroenterology, Urology Class 2 876.1500 2023-05-25
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2024-11-13
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2024-02-21
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2021-11-11
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2022-01-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-01-24
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2024-02-05
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-03-22
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2019-01-25
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2025-05-08
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2023-04-04
HBA Neurosurgical Paddie Neurology Class 2 882.4700 2019-12-31
FRN Pump, Infusion General Hospital Class 2 880.5725 2020-06-24

Official Correspondent

Ephraim Grossman

US Agent Details

Ephraim Grossman Business: Gemstar Inc Email: rose@gemstarinc.com Phone: (845) 4257676

Related Public Records

Same Entity

CBR Enterprise Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K943349 Quinton, Inc. MAHURKAR DUAL LUMEN CATHETER 1995-03-22
K912158 Medical Device Inspection Co., Inc. CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY 1991-10-23
K945777 Smiths Industries Medical Systems, Inc. PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES 1994-12-22
K132890 Mediplus , Ltd. SUPRAPUBIC CATHETER AND INTRODUCER SET 2014-01-17
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2024 ARROW INTERNATIONAL Inc. 2
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024 ARROW INTERNATIONAL Inc. 2
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023 B Braun Medical Inc 2
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024 Becton Dickinson Infusion Therapy Systems Inc. 2
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Z-0030-2014 Perkin Elmer Health Sciences, Inc. 2
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

Similar Registrations

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1721676 Sterigenics U.S., LLC Salt Lake City, UT, US
3012809732 SHIPSERVE NEW ZEALAND LIMITED Ellerslie Auckland, NZ
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013557562. Last updated year: 2026. Please use registration number 3013557562 when referencing this establishment in official correspondence.
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