FDA Device Registration & Listing · Waukegan, IL, US · Registration 1423537
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| PRW | Gastrointestinal Tube Kit | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-06-06 |
| JEB | Table, Surgical With Orthopedic Accessories, Manual | General, Plastic Surgery | Class 1 | 878.4950 | 2012-05-22 |
| QGA | Penile Implant Surgical Accessories | Gastroenterology, Urology | Class 1 | 876.3500 | 2020-03-18 |
| PPI | Hemodialysis Tray (Not A Start/Stop Kit) | Gastroenterology, Urology | Class 2 | 876.5820 | 2018-04-30 |
| OFO | Airway Suction Kit | Anesthesiology | Class 1 | 868.6810 | 2011-11-09 |
| KYW | Container, Liquid Medication, Graduated | General Hospital | Class 1 | 880.6430 | 2002-05-07 |
| PPG | Urinary Drainage Collection Kit | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-04-30 |
| LZH | Pump, Infusion, Enteral | General Hospital | Class 2 | 880.5725 | 2016-08-22 |
| PRP | Balloon Gastrostomy Tube Kit | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-06-05 |
| OFN | Winged Intravenous Catheterization Kit | Cardiovascular | Class 2 | 870.1200 | 2011-11-09 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2008-01-16 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2013-01-24 |
| LZH | Pump, Infusion, Enteral | General Hospital | Class 2 | 880.5725 | 2018-07-27 |
| OKZ | Endometrial Sampling Kit | Obstetrics/Gynecology | Class 2 | 884.1175 | 2011-11-14 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2010-10-18 |
| PJE | Blood/Plasma Collection Device For Dna Testing | Clinical Chemistry | Class 2 | 862.1675 | 2025-02-18 |
| HIB | Speculum, Vaginal, Nonmetal | Obstetrics/Gynecology | Class 2 | 884.4530 | 2009-06-24 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2007-12-05 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2010-11-11 |
| IPM | Cover, Limb | Physical Medicine | Class 1 | 890.3025 | 1994-05-23 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | Class 1 | 872.4565 | 1977-12-23 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2019-03-13 |
| FOS | Catheter, Umbilical Artery | General Hospital | Class 2 | 880.5200 | 2008-01-17 |
| OHD | Gynecological Laparoscopic Kit | Obstetrics/Gynecology | Class 2 | 884.1720 | 2011-10-12 |
| PXC | Personal Protection Kit | General Hospital | Class 1 | 880.6250 | 2018-06-06 |
| PRM | Enteral Administration Kit (Adult & Pediatric) | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-08-09 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2016-10-28 |
| HHT | Spatula, Cervical, Cytological | Obstetrics/Gynecology | Class 2 | 884.4530 | 2019-01-14 |
| ERY | Drape, Surgical, Ent | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-07 |
| PKD | Laceration Tray | General, Plastic Surgery | Class 1 | 878.4014 | 2018-03-15 |
| OGS | Myringotomy Procedure Kit | Ear, Nose, Throat | Class 2 | 874.3880 | 2011-11-09 |
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | Class 1 | 878.4950 | 1995-04-03 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-07-27 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2020-03-20 |
| PXP | Breast Biopsy / Localization Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-02 |
| LWK | Razor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 1999-02-12 |
| PVY | Vasovasostomy Set | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-06-06 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2009-07-07 |
| GAB | Needle, Suturing, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2009-07-08 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2024-08-26 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2024-08-26 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-08-26 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2008-01-11 |
| OGT | Oral Irrigation Kit | Dental | Class 1 | 872.6510 | 2011-11-09 |
| KGY | Bag, Intestine | General, Plastic Surgery | Class 1 | 878.4100 | 2017-03-17 |
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Gastroenterology, Urology | Class 2 | 876.1800 | 2002-02-23 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2018-03-14 |
| MCZ | Suture Removal Kit | General, Plastic Surgery | Class 1 | 878.4800 | 2011-09-19 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-18 |
| GDX | Scalpel, One-Piece | General, Plastic Surgery | Class 1 | 878.4800 | 2003-08-15 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2007-04-20 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2015-09-09 |
| DRS | Transducer, Blood-Pressure, Extravascular | Cardiovascular | Class 2 | 870.2850 | 2013-04-30 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | Anesthesiology | Class 2 | 868.5800 | 2008-01-18 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2013-01-23 |
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | Class 1 | 876.5920 | 2013-06-03 |
| CBT | Arterial Blood Sampling Kit | Anesthesiology | Class 1 | 868.1100 | 1993-02-05 |
| OGC | Continuous Brachial Plexus Block Tray | Anesthesiology | Class 2 | 868.5150 | 2011-11-09 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2015-09-09 |
| OES | Cardiac Catheterization Kit | Cardiovascular | Class 2 | 870.1200 | 2011-11-09 |
| PXF | Sitz Bath Kit | General Hospital | Class 1 | 880.6730 | 2018-06-06 |
| FRZ | Device, Patient Transfer, Powered | General Hospital | Class 2 | 880.6775 | 2019-09-12 |
| OGK | Orotracheal Intubation Guide Kit | Anesthesiology | Class 2 | 868.1400 | 2011-11-09 |
| OGL | Oxygen Administration Kit | Anesthesiology | Class 2 | 868.5655 | 2011-11-09 |
| OKG | Body Fluid Clean Up Kit | General, Plastic Surgery | Class 2 | 878.4040 | 2011-11-11 |
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) | Anesthesiology | Class 1 | 868.5240 | 2011-09-20 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-18 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2007-11-30 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-18 |
| OHL | Pap Smear Kit | Obstetrics/Gynecology | Class 2 | 884.4530 | 2011-11-14 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2011-05-11 |
| GBZ | Catheter, Cholangiography | General, Plastic Surgery | Class 1 | 878.4200 | 2011-11-10 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2013-01-16 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | Obstetrics/Gynecology | Class 1 | 884.1550 | 2006-05-18 |
| NXZ | Dental Hygiene Kit | Dental | Class 1 | 872.6855 | 2011-11-09 |
| FYF | Cap, Surgical | General, Plastic Surgery | Class 1 | 878.4040 | 1990-01-03 |
| EFQ | Gauze/Sponge, Internal | Unknown | Class U | N/A | 2008-01-10 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2008-01-10 |
| KIZ | Dish, Tissue Culture | Hematology | Class 1 | 864.2240 | 2009-03-30 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-18 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2007-04-20 |
| OFT | Spinal Epidural Anesthesia Kit | Anesthesiology | Class 2 | 868.5120 | 2011-11-09 |
| LZH | Pump, Infusion, Enteral | General Hospital | Class 2 | 880.5725 | 2018-07-27 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2008-01-16 |
| FOS | Catheter, Umbilical Artery | General Hospital | Class 2 | 880.5200 | 2014-05-05 |
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | Class 1 | 868.6810 | 1999-03-30 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | Class 2 | 876.5250 | 2011-11-10 |
| EXB | Collector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2011-11-10 |
| KYX | Dispenser, Liquid Medication | General Hospital | Class 1 | 880.6430 | 1999-10-14 |
| PXV | General Purpose Instrument Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-02 |
| OHF | Culdocentesis Kit | Obstetrics/Gynecology | Class 2 | 884.1640 | 2011-11-14 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2023-07-31 |
| PXX | Incision Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-02 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2008-04-15 |
| OFL | Percutaneous Sheath Introducer Kit | Cardiovascular | Class 2 | 870.1340 | 2011-11-09 |
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | Class 1 | 878.4800 | 1995-08-02 |
| OHO | First Aid Kit Without Drug | General, Plastic Surgery | Class 1 | 878.4014 | 2011-11-11 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2009-07-01 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-10 |
| FOD | Device, Occlusion, Umbilical | General Hospital | Class 1 | 880.5950 | 2024-06-10 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2007-04-26 |
| HMW | Drape, Microscope, Ophthalmic | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-11 |
| PXW | Herniorraphy Kit | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-02 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2020-03-18 |
| OGB | Caudal Anesthesia Kit | Anesthesiology | Class 2 | 868.5140 | 2011-11-09 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2014-04-11 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2008-01-16 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2008-01-11 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2005-09-06 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2017-01-05 |
| FXP | Cover, Shoe, Operating-Room | General, Plastic Surgery | Class 1 | 878.4040 | 1999-08-04 |
| OHH | Breast Pump Kit | Obstetrics/Gynecology | Class 2 | 884.5160 | 2011-11-14 |
| GBM | Catheter, Urethral | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-18 |
| PSC | Nasogastric-Gastrojejunal Kit | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-06-06 |
| OGJ | Nerve Block Tray | Anesthesiology | Class 2 | 868.5140 | 2011-09-06 |
| FMG | Stopcock, I.V. Set | General Hospital | Class 2 | 880.5440 | 2013-06-03 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2006-05-12 |
| EYC | Catheter, Upper Urinary Tract | Gastroenterology, Urology | Class 2 | 876.5130 | 2013-01-23 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2019-04-04 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2019-04-04 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2019-04-04 |
| GAL | Suture, Absorbable, Natural | General, Plastic Surgery | Class 2 | 878.4830 | 2019-04-04 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | Class 2 | 878.5020 | 2019-04-04 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2019-04-04 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | General, Plastic Surgery | Class 2 | 878.4495 | 2019-04-04 |
| PWM | Admission Kit (Patient Utensil) | General Hospital | Class 1 | 880.6730 | 2018-06-06 |
| POR | Parenteral Administration Kit | General Hospital | Class 2 | 880.5440 | 2018-03-15 |
| FMP | Protector, Skin Pressure | General Hospital | Class 1 | 880.6450 | 2012-06-25 |
| FCE | Enema Kit | Gastroenterology, Urology | Class 1 | 876.5210 | 2002-02-23 |
| PQE | Ostomy Care Kit | Gastroenterology, Urology | Class 1 | 876.5900 | 2018-06-05 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2011-08-04 |
| NYE | Fixture Mount Kit | Dental | Class 1 | 872.3980 | 2011-11-09 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2019-03-13 |
| PPQ | Transtibial Anterior Cruciate Ligament Kit | Orthopedic | Class 2 | 888.3040 | 2018-06-05 |
| FOS | Catheter, Umbilical Artery | General Hospital | Class 2 | 880.5200 | 2016-06-08 |
| OEV | Cardiopulmonary Resuscitation Aid Kit | Anesthesiology | Class 2 | 868.5915 | 2011-11-09 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2009-05-06 |
| OJG | Neurological Tray | Neurology | Class 1 | 882.4525 | 2009-05-07 |
| KQZ | Component, Traction, Non-Invasive | Orthopedic | Class 1 | 888.5890 | 2017-03-15 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2002-05-07 |
| GBM | Catheter, Urethral | Gastroenterology, Urology | Class 2 | 876.5130 | 2007-12-17 |
| NXA | Tracheotomy Care Kit | Anesthesiology | Class 2 | 868.5800 | 2011-09-08 |
| PVS | Fetal Blood Sampling Kit (Excludes Hiv Testing) | Obstetrics/Gynecology | Class 2 | 884.1560 | 2018-06-06 |
| PXG | Spill Kit | General Hospital | Class 1 | 880.6890 | 2018-06-06 |
| NWT | Endoscopic Cholangiogram Kit | Gastroenterology, Urology | Class 2 | 876.1500 | 2011-11-10 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-07-27 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-12-11 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-12-11 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2012-05-07 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2007-12-18 |
| EBO | Denture Repair Kit | Dental | Class 2 | 872.3570 | 2011-11-09 |
| PSG | Percutaneous Endoscopic Gastrostomy Kit | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-06-06 |
| OKW | Seminal Fluid Collection Kit | Obstetrics/Gynecology | Class 2 | 884.5300 | 2011-11-14 |
| OJU | Skin Prep Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2011-06-27 |
| PEV | Dialysis Administration Kit | Gastroenterology, Urology | Class 2 | 876.5820 | 2015-06-04 |
| PVV | Paracervical Anesthesia Kit | Obstetrics/Gynecology | Class 2 | 884.5100 | 2018-06-06 |
| OJA | Intravenous Extension Tubing Set | General Hospital | Class 2 | 880.5440 | 2013-01-29 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2017-12-05 |
| OFG | Ct Biopsy Tray | Cardiovascular | Class 2 | 870.4075 | 2011-11-09 |
| PKE | Laparoscopic Cholecystectomy Kit | General, Plastic Surgery | Class 1 | 878.4800 | 2018-03-15 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2008-01-10 |
| JXA | Kit, Screening, Urine | Microbiology | Class 1 | 866.2660 | 2014-10-28 |
| PKF | D And C Tray | Unknown | Class N | N/A | 2016-01-21 |
| BYX | Tubing, Pressure And Accessories | Anesthesiology | Class 1 | 868.5860 | 2001-06-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-10 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2010-06-28 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2024-02-07 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2024-02-07 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2024-02-07 |
| GAO | Suture, Nonabsorbable | General, Plastic Surgery | Class 2 | 878.4495 | 2021-05-14 |
| PIO | Enteral Specific Transition Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2015-06-10 |
| OJW | Shave Prep Kit | General, Plastic Surgery | Class 2 | 878.4370 | 2011-06-27 |
| OFW | Restorative Instrument And Component Tray | Dental | Class 2 | 872.3690 | 2011-11-09 |
| OGV | Tracheostomy Cleaning Tray | Anesthesiology | Class 2 | 868.5800 | 2011-11-09 |
| PVM | Endoscopic Ventricular Catheter Placement Kit | Neurology | Class 2 | 882.4100 | 2018-06-06 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2013-06-26 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2018-07-27 |
| PYC | Paracentesis Tray | General, Plastic Surgery | Class 1 | 878.4200 | 2018-07-02 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2026-02-10 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2026-02-10 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2026-02-10 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-02-10 |
| PPK | Peritoneal Dialysis Tubing Kit | Gastroenterology, Urology | Class 2 | 876.5630 | 2018-05-10 |
| HHK | Curette, Suction, Endometrial (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1175 | 2008-06-11 |
| LWH | Counter, Sponge, Surgical | General Hospital | Class 1 | 880.2740 | 2019-10-23 |
| LKB | Pad, Alcohol, Device Disinfectant | Unknown | Class U | N/A | 2008-01-10 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | Class 1 | 878.4450 | 2005-07-11 |
| PRT | Gastric Irrigation And Aspiration Kit | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-06-05 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-05-22 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2011-04-19 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2010-12-30 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2016-06-24 |
| PYJ | Ulcer Wound Tray | General, Plastic Surgery | Class 1 | 878.4014 | 2018-07-02 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | Gastroenterology, Urology | Class 1 | 876.5250 | 2001-08-30 |
| OHC | Obstetrical Vacuum Delivery Kit | Obstetrics/Gynecology | Class 2 | 884.4340 | 2011-11-14 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | Class 2 | 868.1400 | 2010-08-10 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | Gastroenterology, Urology | Class 1 | 876.5250 | 1989-04-26 |
| PSK | Replacement Gastrostomy Feeding Catheter Tray | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-06-06 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2007-04-20 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2008-01-10 |
| KYP | Snake Bite Suction Kit | General Hospital | Class 1 | 880.5740 | 2011-11-14 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2018-08-02 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2018-07-27 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2014-05-05 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | General Hospital | Class 2 | 880.5970 | 2014-05-05 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2022-05-25 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | Gastroenterology, Urology | Class 2 | 876.5980 | 2022-05-25 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2019-01-25 |
| PNR | Enteral Syringes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-01-06 |
| KDT | Container, Specimen Mailer And Storage, Sterile | Pathology | Class 1 | 864.3250 | 2002-05-07 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2008-01-10 |
| FSD | Binder, Abdominal | General Hospital | Class 1 | 880.5160 | 1996-12-16 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2009-09-17 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2008-01-10 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2007-04-20 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | Unknown | Class U | N/A | 2008-01-10 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2008-01-11 |
| JYA | Scissors, Wire Cutting, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2007-04-26 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 1995-08-02 |
| PXJ | Umbilical Catheter Insertion Tray | General Hospital | Class 2 | 880.5200 | 2018-06-06 |
| PXQ | Burn Dressing Tray | General, Plastic Surgery | Class 1 | 878.4022 | 2018-07-02 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-07-27 |
| DYN | Mouthpiece, Saliva Ejector | Dental | Class 1 | 872.6640 | 2004-06-03 |
| OFZ | Blood Specimen Collection Kit (Excludes Hiv Testing) | Anesthesiology | Class 1 | 868.1100 | 2011-11-09 |
| OJF | Hysterectomy Kit | Obstetrics/Gynecology | Class 2 | 884.4530 | 2011-07-19 |
| FOS | Catheter, Umbilical Artery | General Hospital | Class 2 | 880.5200 | 2008-01-16 |
| LWE | Bone Marrow Collection/Transfusion Kit | Unknown | Class 2 | N/A | 2011-11-11 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-04-20 |
| PWU | Clean-Up Kit | General Hospital | Class 1 | 880.6890 | 2018-06-06 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2007-11-09 |
| PRU | Gastric Lavage Kit (Adult Or Pediatric Use) | Gastroenterology, Urology | Class 2 | 876.4370 | 2018-06-05 |
| PXO | Bone Marrow Biopsy Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-02 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2016-05-23 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2016-05-23 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 1999-08-04 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4290 | 2011-06-20 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2008-04-24 |
| PPB | Foley Catheter Kit (Excludes Hiv Testing) | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-04-20 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2007-12-05 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2007-04-26 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2008-01-10 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2007-12-05 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 1977-12-31 |
| HHT | Spatula, Cervical, Cytological | Obstetrics/Gynecology | Class 2 | 884.4530 | 2019-01-14 |
| PIN | Kidney Perfusion Kit | Gastroenterology, Urology | Class 2 | 876.5880 | 2018-03-15 |
| SDV | Clinical Electronic Thermometer | General Hospital | Class 2 | 880.2910 | 2026-02-20 |
| BYZ | Trap, Sterile Specimen | General Hospital | Class 2 | 880.6740 | 2021-06-25 |
| OGG | Humidifier Nebulizer Kit | Anesthesiology | Class 2 | 868.5450 | 2011-11-09 |
| POQ | Blood Transfusion Kit | General Hospital | Class 2 | 880.5440 | 2018-03-15 |
| HIB | Speculum, Vaginal, Nonmetal | Obstetrics/Gynecology | Class 2 | 884.4530 | 2009-06-24 |
| HFX | Clamp, Circumcision | Obstetrics/Gynecology | Class 2 | 884.4530 | 2009-07-02 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2007-04-20 |
| POZ | Biopsy Needle Kit | Gastroenterology, Urology | Class 2 | 876.1075 | 2018-03-19 |
| GBX | Catheter, Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 1998-08-17 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2007-04-26 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2011-07-08 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2020-03-20 |
| MIA | Needle, Spinal, Short Term | Anesthesiology | Class 2 | 868.5150 | 1999-06-23 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2007-04-20 |
| IME | Pack, Hot Or Cold, Reusable | Physical Medicine | Class 1 | 890.5700 | 1994-07-14 |
| PNR | Enteral Syringes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2016-12-20 |
| OFF | Central Venous Catheter Tray | Cardiovascular | Class 2 | 870.1140 | 2011-11-09 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2017-07-11 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2017-07-11 |
| MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular | Class 3 | 870.5310 | 2020-10-07 |
| PYE | Staple Removal Kit | General, Plastic Surgery | Class 1 | 878.4760 | 2018-07-02 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2019-03-13 |
| FFP | Dilator, Rectal | Gastroenterology, Urology | Class 1 | 876.5450 | 2011-11-10 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2022-05-05 |
| PRQ | Esophageal Dilator Kit | Gastroenterology, Urology | Class 2 | 876.5365 | 2018-06-05 |
| OIA | Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing) | Pathology | Class 1 | 864.3250 | 2011-11-09 |
| GDT | Staple, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4760 | 2009-06-30 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-10 |
| OGD | Custom Anesthesia Tray | Anesthesiology | Class 2 | 868.5120 | 2011-11-09 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2023-08-17 |
| CBH | Device, Fixation, Tracheal Tube | Anesthesiology | Class 1 | 868.5770 | 2025-08-12 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2009-05-19 |
| OFE | Central Venous Blood Pressure Kit | Cardiovascular | Class 2 | 870.1140 | 2011-06-27 |
| KYR | Bag, Ice | General Hospital | Class 1 | 880.6050 | 2006-04-11 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-04-20 |
| HED | Douche Apparatus, Vaginal, Therapeutic | Obstetrics/Gynecology | Class 1 | 884.5900 | 2002-02-23 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2011-10-06 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2003-08-05 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2022-07-20 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2020-01-31 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 1977-12-31 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2001-08-10 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2007-12-03 |
| LRQ | Tracheostomy And Nasal Suctioning Kit | Unknown | Class 1 | N/A | 2011-11-09 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2013-06-25 |
| PSP | Intracranial Pressure & Temperature Monitoring Kit | Neurology | Class 2 | 882.1620 | 2018-06-06 |
| FOK | Pad, Neonatal Eye | General Hospital | Class 1 | 880.5270 | 2006-05-26 |
| MAC | Decontamination Kit | General, Plastic Surgery | Class 1 | 878.4014 | 2011-11-11 |
| NWN | Laparoscopic Bone Anchor Urethropexy Instrument Kit | Orthopedic | Class 2 | 888.3040 | 2018-03-15 |
| OGU | Pierced Ear/Entry Cleaning Tray | Ear, Nose, Throat | Class 1 | 874.4420 | 2011-11-09 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2019-06-24 |
| OKF | Body Fluid Disposal Kit | General, Plastic Surgery | Class 2 | 878.4040 | 2011-11-11 |
| KNW | Instrument, Biopsy | Gastroenterology, Urology | Class 2 | 876.1075 | 2019-06-17 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2006-04-11 |
| PXK | Vascular Access Port Kit | General Hospital | Class 2 | 880.5965 | 2018-07-02 |
| OFH | Digital Angiography Tray | Cardiovascular | Class 2 | 870.1650 | 2011-11-09 |
| OEU | Cardiopulmonary Bypass Catheter Kit | Cardiovascular | Class 2 | 870.4210 | 2011-11-09 |
| KXO | Monitor, Pressure, Intrauterine | Obstetrics/Gynecology | Class 2 | 884.2700 | 2006-09-22 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2012-05-07 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2021-08-16 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2007-04-20 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2019-06-17 |
| KEW | Slides, Microscope | Pathology | Class 1 | 864.3010 | 2014-10-28 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2008-01-28 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2006-05-18 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2008-01-10 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4200 | 2013-01-31 |
| FPK | Tubing, Fluid Delivery | General Hospital | Class 2 | 880.5440 | 2008-01-28 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 1977-12-23 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2005-04-06 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2009-11-02 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2008-01-18 |
| FMG | Stopcock, I.V. Set | General Hospital | Class 2 | 880.5440 | 2022-11-11 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2008-01-10 |
| NOD | Board, Arm (With Cover), Non-Sterile | General, Plastic Surgery | Class 1 | 878.3910 | 2024-05-29 |
| OEX | Cardiovascular Catheter Sheath Introducer Kit | Cardiovascular | Class 2 | 870.1340 | 2011-11-09 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2007-11-30 |
| OJR | Vacuum Powered Body Fluid Collection Kit | General, Plastic Surgery | Class 2 | 878.4780 | 2011-11-11 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2008-06-20 |
| FMJ | Manometer, Spinal-Fluid | General Hospital | Class 2 | 880.2500 | 2022-03-21 |
| EYX | Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | General, Plastic Surgery | Class 2 | 878.4370 | 2017-08-11 |
| MPO | Infant Heel Warmer (Chemical Heat Pack) | Physical Medicine | Class 1 | 890.5710 | 2008-02-04 |
| OEQ | Angiography/Angioplasty Kit | Cardiovascular | Class 2 | 870.1650 | 2011-06-27 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-10 |
| PXB | Percutaneous Introducer Kit | General Hospital | Class 2 | 880.5570 | 2018-06-06 |
| PVP | Neurological Test Kit | Neurology | Class 1 | 882.1750 | 2018-06-06 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2006-04-11 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2008-01-17 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2008-01-11 |
| OGF | Glossopharyngeal Anesthesia Kit | Anesthesiology | Class 2 | 868.5120 | 2011-11-09 |
| PPP | Disposable Joint Aspiration/Injection Kit | General, Plastic Surgery | Class 1 | 878.4800 | 2018-05-10 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2007-12-03 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2007-11-30 |
| PTM | Syringe, Balloon Inflation, Exempt | Cardiovascular | Class 2 | 870.1650 | 2020-08-27 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2008-01-17 |
| OFJ | Lead Introducer Kit | Cardiovascular | Class 2 | 870.1340 | 2011-11-09 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2008-01-11 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-18 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2008-04-24 |
| NWU | Endoscope Introducer Kit | Gastroenterology, Urology | Class 2 | 876.1500 | 2011-11-10 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2008-01-10 |
| OGQ | Ear Irrigation Kit | General Hospital | Class 1 | 880.6960 | 2011-11-09 |
| PYF | Sterile Puncture Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-02 |
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | Gastroenterology, Urology | Class 2 | 876.5250 | 2011-07-11 |
| OIP | Radiology-Diagnostic Kit | Radiology | Class 2 | 892.1680 | 2011-06-27 |
| OGE | Epidural Anesthesia Kit | Anesthesiology | Class 2 | 868.5120 | 2011-06-27 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-07-27 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2007-04-20 |
| OJK | Eye Tray | Ophthalmic | Class 2 | 886.4790 | 2011-06-27 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | Cardiovascular | Class 2 | 870.5550 | 2004-06-01 |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | General Hospital | Class 2 | 880.5570 | 2018-06-06 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2016-07-11 |
| PSB | Nasogastric Feed Tube Kit | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-06-06 |
| PYK | Venous Ulcer Kit | General, Plastic Surgery | Class 1 | 878.4014 | 2018-07-02 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2007-12-17 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2023-11-28 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 2026-06-12 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2015-05-14 |
| LRS | I.V. Start Kit | General Hospital | Class 2 | 880.5200 | 2011-09-01 |
| PPD | Universal Drainage Tray | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-04-30 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2018-07-27 |
| KME | Bedding, Disposable, Medical | General Hospital | Class 1 | 880.6060 | 2001-08-10 |
| ILG | Stocking, Elastic | Physical Medicine | Class 1 | 890.3475 | 2003-07-01 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2007-04-20 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2014-05-14 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2018-07-27 |
| PPH | Single Needle With Uni-Directional Pump Kit | Gastroenterology, Urology | Class 2 | 876.5820 | 2018-04-30 |
| CCX | Support, Patient Position | Anesthesiology | Class 1 | 868.6820 | 2010-05-03 |
| FRQ | Tube, Levine | Gastroenterology, Urology | Class 2 | 876.5980 | 2014-03-24 |
| NWP | Suprapubic Cystostomy Catheter Kit | Gastroenterology, Urology | Class 2 | 876.5090 | 2011-11-11 |
| OFB | Catheter Guide Wire Kit | Cardiovascular | Class 2 | 870.1330 | 2011-11-09 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2021-11-29 |
| PXI | Thoracentesis Tray | General Hospital | Class 2 | 880.5570 | 2018-06-06 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | Class 1 | 862.2050 | 2009-05-15 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-04-12 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2017-08-14 |
| MCY | Wound Dressing Kit | General Hospital | Class 2 | 880.5075 | 2011-11-11 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2007-04-26 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2008-01-11 |
| EXR | Urinometer, Mechanical | Gastroenterology, Urology | Class 2 | 876.1800 | 1993-01-14 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2018-12-19 |
| OGI | Nasal Endotracheal Tube Holder Kit | Anesthesiology | Class 1 | 868.5770 | 2011-11-09 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | Gastroenterology, Urology | Class 2 | 876.5980 | 2012-10-12 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 1993-01-08 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-04-26 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2010-10-25 |
| OHM | Cesarean Section Tray | Obstetrics/Gynecology | Class 2 | 884.1720 | 2011-07-19 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2013-01-24 |
| HMP | Pad, Eye | General, Plastic Surgery | Class 1 | 878.4440 | 2001-07-26 |
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | Class 1 | 878.5910 | 2021-08-16 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2005-07-11 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2019-12-11 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | Gastroenterology, Urology | Class 2 | 876.5980 | 2019-12-11 |
| OII | Arthrogram Tray | Radiology | Class 2 | 892.1650 | 2011-06-27 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2015-05-14 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2026-02-19 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2009-10-27 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2010-07-02 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2007-12-18 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2022-05-05 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2008-01-10 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2006-04-11 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2015-06-03 |
| PWZ | Mid-Stream Collection Kit | General Hospital | Class 1 | 880.6730 | 2019-06-28 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-07-27 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2017-04-04 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2011-04-14 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2017-08-14 |
| OFA | Cardiovascular Surgical Instruments Tray | Cardiovascular | Class 1 | 870.4500 | 2009-05-07 |
| PRR | Feeding Tube Kit | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-06-05 |
| OJH | Orthopedic Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2009-05-07 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2018-07-27 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2013-06-11 |
| PVT | Maternity Kit | Obstetrics/Gynecology | Class 1 | 884.5435 | 2018-06-06 |
| OGW | Tracheostomy Kit | Anesthesiology | Class 2 | 868.5800 | 2011-11-09 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2014-04-29 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2013-02-20 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2007-04-20 |
| HCC | Device, Biofeedback | Neurology | Class 2 | 882.5050 | 2023-11-29 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2009-06-15 |
| OKE | Port Introducer Kit | General Hospital | Class 2 | 880.5965 | 2011-09-28 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2001-07-27 |
| OHZ | Urine Transport Kit (Excludes Hiv Testing) | Pathology | Class 1 | 864.3250 | 2011-11-09 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2009-09-23 |
| MLS | Labor And Delivery Kit | Obstetrics/Gynecology | Class 2 | 884.4530 | 2008-06-17 |
| OKH | Body Fluids Barrier Kit | General, Plastic Surgery | Class 2 | 878.4040 | 2011-11-10 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2001-08-22 |
| PPR | Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures | Orthopedic | Class 2 | 888.1100 | 2018-06-05 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2007-11-30 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2008-01-10 |
| PVW | Pudendal Anesthesia Kit | Obstetrics/Gynecology | Class 2 | 884.5100 | 2018-06-06 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2007-12-05 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-04-26 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-18 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2021-08-17 |
| OKX | Trocar Kit | Obstetrics/Gynecology | Class 2 | 884.1720 | 2011-11-14 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2013-09-03 |
| OKI | Emergency Response Safety Kit | General, Plastic Surgery | Class 2 | 878.4040 | 2011-11-11 |
| BWN | Table And Attachments, Operating-Room | General, Plastic Surgery | Class 1 | 878.4950 | 2011-06-22 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2013-02-01 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2016-03-24 |
| GCD | Connector, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2013-07-17 |
| PPL | Single Needle (Co-Axial Flow) Dialysis Kit | Gastroenterology, Urology | Class 2 | 876.5820 | 2018-05-10 |
| PVX | Vaginal Examination Tray | Obstetrics/Gynecology | Class 2 | 884.4530 | 2018-06-06 |
| PVL | Endoscopic Shunt Placement Kit | Neurology | Class 2 | 882.5550 | 2018-06-06 |
| GBW | Catheter, Peritoneal | General, Plastic Surgery | Class 1 | 878.4200 | 1995-04-04 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | Class 1 | 878.5900 | 2009-06-25 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2007-04-26 |
| PPC | Male External Catheterization Kit (Excludes Hiv Testing) | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-04-30 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2008-01-10 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-07-27 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2018-07-27 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2017-06-19 |
| NYF | Gingival Retraction Kit | Dental | Class 1 | 872.4565 | 2011-11-09 |
| PXS | Cholecystectomy Kit | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-02 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2017-03-07 |
| MJG | Device, Percutaneous, Biopsy | General, Plastic Surgery | Class 1 | 878.4800 | 2011-11-11 |
| MLT | Pelvic Exam Kit | Obstetrics/Gynecology | Class 2 | 884.4530 | 2011-09-13 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 1995-04-03 |
| OXQ | Dressing Change Tray | General Hospital | Class 1 | 880.5075 | 2011-09-06 |
| PYG | Suction Catheter Kit | General, Plastic Surgery | Class 1 | 878.4200 | 2018-07-02 |
| OFK | Percutaneous Atrial Catheter Kit | Cardiovascular | Class 2 | 870.1250 | 2011-11-09 |
| MUI | Media, Coupling, Ultrasound | Radiology | Class 2 | 892.1570 | 2020-09-14 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2010-09-20 |
| FDE | Laparoscopy Kit | Gastroenterology, Urology | Class 2 | 876.1500 | 2011-06-27 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | Class 2 | 882.5890 | 2008-01-10 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2013-01-23 |
| PYD | Pelviscopy Kit | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-02 |
| MYK | Kit, Cord Blood Collection | Unknown | Class N | N/A | 2013-02-01 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2014-01-23 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2017-01-20 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | Gastroenterology, Urology | Class 2 | 876.5980 | 2017-01-20 |
| OGR | Ear, Nose, And Throat Surgical Tray | Ear, Nose, Throat | Class 1 | 874.4420 | 2011-06-27 |
| JRC | Micro Pipette | Clinical Chemistry | Class 1 | 862.2050 | 1992-08-19 |
| MHW | Dressing, Compression | General Hospital | Class 1 | 880.5075 | 2010-09-17 |
| PXD | Prep Kit | General Hospital | Class 1 | 880.6250 | 2018-06-06 |
| MFY | Endothelial Cell Harvesting Kit | Cardiovascular | Class 2 | 870.4075 | 2011-11-09 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-05-06 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2020-05-06 |
| GBQ | Catheter, Continuous Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 2021-05-14 |
| FTA | Light, Surgical, Accessories | General, Plastic Surgery | Class 2 | 878.4580 | 2016-04-14 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2006-03-20 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | Class 2 | 884.1730 | 2013-05-13 |
| EZD | Catheter, Straight | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-18 |
| IKD | Cable, Electrode | Physical Medicine | Class 2 | 890.1175 | 2001-08-31 |
| KPE | Container, I.V. | General Hospital | Class 2 | 880.5025 | 2008-01-11 |
| FSY | Light, Surgical, Ceiling Mounted | General, Plastic Surgery | Class 2 | 878.4580 | 2016-08-22 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 1994-05-23 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2011-06-17 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2011-06-17 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 1977-12-31 |
| LEA | Preservative, Cytological | Pathology | Class 1 | 864.4010 | 2015-11-11 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 1999-08-04 |
| KOX | Solvent, Adhesive Tape | General, Plastic Surgery | Class 1 | 878.4730 | 2004-04-07 |
| OHG | Circumcision Tray | Obstetrics/Gynecology | Class 2 | 884.4530 | 2011-06-27 |
| NNI | Container, Specimen, Non-Sterile | Pathology | Class 1 | 864.3250 | 2012-02-09 |
| KST | System, Blood Collection, Vacuum-Assisted, Manual | Hematology | Class 1 | 864.9125 | 2021-12-05 |
| PWL | Oral Surgery Tray | Dental | Class 1 | 872.4565 | 2018-06-06 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2022-05-05 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2015-04-29 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-18 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | Class 2 | 880.6740 | 2001-07-27 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2007-04-20 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2009-07-07 |
| OFI | Laser Blood Flow Kit | Cardiovascular | Class 2 | 870.2120 | 2011-11-09 |
| OHE | Forensic Evidence Sexual Assault Kit | Obstetrics/Gynecology | Class 2 | 884.1630 | 2011-11-14 |
| PWO | Blood Administration Kit | General Hospital | Class 2 | 880.5440 | 2018-06-06 |
| OID | Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) | Microbiology | Class 1 | 866.2900 | 2011-11-09 |
| OKU | Emergency Obstetrical Kit | Obstetrics/Gynecology | Class 1 | 884.4520 | 2011-11-14 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2018-07-27 |
| HHD | Pad, Menstrual, Unscented | Obstetrics/Gynecology | Class 1 | 884.5435 | 2008-06-02 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2007-04-26 |
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Clinical Chemistry | Class 2 | 862.1675 | 2018-06-05 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2008-01-11 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2008-04-16 |
| FOX | Stand, Infusion | General Hospital | Class 1 | 880.6990 | 1995-08-03 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | Class 1 | 862.2050 | 2009-07-15 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2008-04-15 |
| NWI | Electrosurgical Electrode Kit | Gastroenterology, Urology | Class 2 | 876.4300 | 2011-11-10 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2014-07-30 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-10 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2013-05-03 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2023-02-02 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-18 |
| PFU | Tissue Processing Kit | Unknown | Class N | N/A | 2018-03-15 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 1977-12-31 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | Class 2 | 862.1675 | 2008-01-11 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2011-10-06 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004839227 | Cardinal Health Malta 212 Ltd | Marsa, MT |
| 3015541720 | Cardinal Health Germany Manufacturing GmbH | Halberstadt Saxony-Anhalt, DE |
| 1033903 | Cardinal Health | Greenwood, SC, US |
| 9611018 | Cardinal Health Ireland Manufacturing Limited | TULLAMORE Offaly, IE |
| 8040459 | Kendall-Gammatron Limited | SAMPRAN Nakhon Pathom, TH |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K060316 | Fresenius Kabi Deutschland GmbH | COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS | 2006-06-23 |
| K880350 | Honway International Co. | YUE/FA DISPOSABLE SYRINGE | 1988-02-16 |
| K003571 | Terumo Medical Corp. | SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE | 2001-02-12 |
| 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 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0003-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes |
| Z-0004-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes |
| Z-0005-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes |
| Z-0005-2024 | Fresenius Medical Care Holdings, Inc. | 2 | 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case |
| Z-0006-2024 | Fresenius Medical Care Holdings, Inc. | 2 | 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3009888344 | Isomedix Operations Inc | El Paso, TX, US |
| 9616088 | Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, MX |
| 3004111573 | Sterigenics US LLC | Grand Prairie, TX, US |
| 3007329020 | Cardinal Health 200, LLC | El Paso, TX, US |
| 1643817 | ISOMEDIX OPERATIONS INC | EL PASO, TX, US |
1423537 when referencing this establishment in official correspondence.