Isomedix Operations, Inc

FDA Device Registration & Listing · ONTARIO, CA, US · Registration 2032098

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
2032098
FEI Number
3003058448
Entity Name
Isomedix Operations, Inc
City/State/Country
ONTARIO, CA, US
Establishment Address
1000 Sarah Pl, ONTARIO, CA 91761, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERIS Corporation (Owner Number: 1527821)
Owner / Operator Contact Address
5960 Heisley Rd, --, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

KeySurgical6941 (LS) - Vascular Loops Syntech7829 (NT) - The Ahn Tray/ Ahn Tray Merit1383 (NT,SN) - StayFIX Fixation Device PFMMedical6614 (TM) - ASEPT Drainage Catheter Dressing Kit (Ref M7041) Ursel11054 (MN) - TRU-FIX Catheter Fixation Kit Insulet5490 (NR) - PodPals Adhesive Overlay Insulet5490 (NR) - Adhesive Overlay Xenco6850 (NT) - SetX Cervical Interbody System Xenco6850 (NT) - Xenco Medical Posterior Cervical System Biogennix6382 (NT) - Agilon Eagle1350 (NT,SN) - Blackhawk Cervical Spacer System DJO3655 (NT,LS,LN) - Adaptable, Leg Positioner Disposable Kit DJO3655 (NT,LS) - Adaptable Arm Positioner Disposable Kit DJO3655 (NT,LS,LN) - Adaptable, Knee Positioner Disposable Kit DJO3655 (NT,LS,LN) - Adaptable, UE Disposable Kit DJO3655 (NT,LS) - Adaptable Retractor Holder Sleeve, 5PK LSO2556 (NT) - VYCOR VIEWSITE BRAIN ACCESS SYTEM Avanos2508 (EP1,EP2,NT) - MIC LOW PROFILE GASTROSTOMY TUBE Avanos2508 (EP1,EP2,NT) - CORFLO* PEG Kit Eagle1350 (NT,SN) - Acumed Anatomic Radial Head Eagle1350 (NT,SN) - Bone Screw 3.5mm SurgicalSpecialties6945 (NT,TM) - Nylon Sutures Eagle1350 (NT,SN) - Guide Wire Eagle1350 (NT,SN) - External Fixator Xenco6850 (NT) - Sorrento™ Bone Graft Substitute Eagle1350 (NT,SN) - Octane PEEK Vertebral Body Replacement Carefusion (EP1) - Gemini/Alaris Pump Module sets Carefusion5709 (EP1) - Alaris Pump Module SmartSite Low Sorbing Infusion Set Carefusion (NT) - set, administration, intravascular UnicareBiomed3455 (NT) Cytoflex mesh Amphenol15397 (NT) - ITE transducer array Amphenol15397 (NT) - Novo TTF 100L System Acumed4864 (NT) - Biotrak Headless Resorbable Compression Screw Eagle1350 (NT,SN) - Octane PEEK Vertebral Body Replacement Ecomed7308 (LN) - Sureglide LSO2556 (NT) - C Safe Carefusion (NT) - Set, administration, intravascular Eagle1350 (NT,SN) - Cortical Bone Screw Acumed4864 (NT) - Acutrak 3 Headless Compression Screw System Eagle1350 (NT,SN) - External Fixator Eagle1350 (NT,SN) - Orthopaedic Wires Eagle1350 (NT,SN) - Osteo-Clage Cerclage Cable System LSO2556 (NT) - Ormco VectorTAS Mini Screw Biogennix6382 (NT) - OsteoSpan BeInnovative11045 (LN) - Rotolock Cord Management System Hydrofera (NR, WH) - Instrument Wipe SurgicalTech4007 (LS) - FlexiTip, FlexiTip XL, FlexiTip XL-R Etex2142 (NR) - Precision Cannula 150 mm PhoenixMed2991 (SP) - Various Instruments Acuderm1463 (WH,LS) - Acu-Dispo-Ce PhoenixMed2991 (SP) - Instrument, manual, surgical, general use Abyrx4508 (WH) - Abyrx Putty Applicator Protech3048 (TM) - INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Protech3048 (TM) - PHANTOM ML LIGHT CABLE Design2052 (NR) - CTS Relief Kit SMC_Amery (LS) - Steripath Micro Blood Collection System Carefusion5709 (TM) - Gravity Sets Carefusion5709 (TM) - Medline IV Admin Set Carefusion (NT) - Set, administration, intravascular Eagle1350 (NT,SN) - Acumed Scapula Congruent Bone Plate Merit1383 (SN,NT) - Futura Safety Scalpel BVI1689 (EP1) - Beaver Sclerotome Blade BVI1689 (EP1) - Beaver Mini-Blades BVI1689 (EP1) - Beaver Pocket Blade BVI1689 (EP1) - BeaverGuard Blade Eagle1350 (NT,SN) - Bone Plate System Neilmed6807 (NT ) - NeilMed NasaMist Isotonic Saline Spay 177 mL Neilmed6807 (NT,SN*) - CVS SALINE NSL MST Neilmed6807 (NT,SN*) - Nasamist Saline Spray Full Stream, Gentle Stream and Medium Stream Neilmed6807(NT,SN*) - Nasamist Hypertonic Spray 125ml Neilmed6807 (NT,SN*) - PediaMist Neilmed6807 (NT,SN*) - Nasamist Saline Spray Pediatric Neilmed6807 (NT,SN*) - NasaMist Neilmed6807 (NT,SN*) - Caring Mill Saline Spray 125 mL Neilmed6807 (NT,SN*) - CVS Saline Nasal Mist Neilmed6807 (NT,SN*) - Target Nasal Spray Neilmed6807 (NT ) - NeilMed Naspira Drops Neilmed6807 (NT ) - NeilMed NasaMist Isotonic Saline Spay 75 mL Neilmed6807 (NT,SN*) - NeilMed Nasamist Hypertonic Saline Spray Neilmed6807 (NT,SN*) - Life Brand Sterile Saline Nasal Mist Neilmed6807 (NT,SN*) - Himalays Chandra - Neti Spray (Sterile Saline Spray) Neilmed6807 (NT,SN*) - Himalays Chandra - Neti Spray (Extra Strength Sterile Saline Spray) Neilmed6807 (NT ) - NeilMed NasaMist Isotonic Saline Spay 125 mL Neilmed6807 (NT,SN*) - Nasamist All-in-one Saline Spray Nellcor9073 (NT) - Hollow Laparoscopic Electrode, Flat L-Hook Tip, 28 cm Nellcor9073 (NT) - Opti4 Hollow Laparoscopic Electrode, Wire J-hook Tip, 28 cm BVI1689 (EP1) - Beaver Mini-Blades Acumed4864 (SN,NT) - Acumed Clavicle Hook Plate Carefusion (EP1,SN,LS,NT) - Alaris Safety Male Luer Eagle1350 (NT,SN) - Acumed - Radius Rod BD9423 (MN) - Personal Catheter BD9423 (MN) - Magic3 BD9423 (NT) - HydroSil BD9423 (NT) - Hydro Soft BVI1689 (EP1) - Atomic Edge Knife BVI1689 (EP1,CH1) - Beaver Micro-Sharp® Blade BVI1689 (EP1) - Beaver Xstar Knives BVI1689 (EP1) - Beaver Micro-Unitome Knife BVI1689 (EP1) - Beaver Sideport MVR Knife BVI1689 (EP1) - Beaver Optimum Knife BVI1689 (EP1, CH1)- Beaver Micro-Sharp® Blade BVI1689 (EP1) - Beaver Swivel Fixation Ring 13mm BVI1689 (EP1) - Beaver Xstar Safety Slit Knife BVI1689 (EP1) - CustomEyes BVI1689 (EP1) - Viscoflow Cannula Biomeric6631 (LN) - TrabEx BVI1689 (EP1) - Beaver Xstar Slit Knife Avanos2508 (NT) - MIC G Eagle1350 (NT,SN) - Octane Straight Intervertebral Fusion Device Eagle1350 (SN,NT) - Bulb & Bladder Amphenol15397 (NT) - INE Transducer Array White Amphenol15397 (NT) - ILE Transducer Array Large ILE1030 Amphenol15397 (NT) - INE Transducer Array Amphenol15397 (NT) - ILE Transducer Array Small Amphenol15397 (NT) - ILE Transducer Array Large SurgicalSpecialties6945 (NT) - Collagen Plugs Tyber6592 (WH,CH1) - Tyber Medical PT Interbody Spacer System Protech3048 (NT) - Continuum ACDF Implant System Intuitive5779 (NT) - Si Harmonic ACE Insert Eagle1350 (NT,SN) - Polarus Cap Screw Merit1383 (SN,NT) - Safeguard Pressure Assisted Dressing (12cm) Eagle1350 (NT) - TriMed EOS Small Bone Fixation System -Staples & Pins Nitinol Staple Eagle1350 (NT,SN) - Trimed Nitinol Staple System Eagle1350 (NT,SN) - Congruent Bone Plate System Eagle1350 (NT,SN) - Acutrak SurgicalSpecialties6945 (NT,TM) - Silk Sutures Eagle1350 (NT,SN) - Acumed - Tension Band Pin Eagle1350 (NT,SN) - Acumed Small Bone Locking Rod Biomerics6631 (SN) - T-DOC Urodynamic Catheter Eagle1350 (NT,SN) - INNate 3.6 system BVI1689 (EP1) - Extend™ Synthetic Implants (0.2mm X 2mm) BVI1689 (EP1) - Extend™ Synthetic Implants (0.5mm X 2mm) BVI1689 (EP1) - Extend™ Synthetic Implants (0.3mm X 2mm) BVI1689 (EP1) - Extend™ Synthetic Implants (Variety Pack) BVI1689 (EP1) - Extend™ Synthetic Implants (0.4mm X 2mm Terumo2207 (NT) - Rika Plasma Bottle Xenco6850 (NT) - SETx Cervical Plate System; Xenco Medical Cervical Plate System Xenco6850 (NT) - Xenco Medical Cervical Interbody System Eagle1350 (NT,SN) - Acutrak Plus Fixation System Neilmed6807 (NT,SN*) - NeilMed Wound Wash Neilmed6807 (NT,SN*) - NeilMed Piercing After Care Neilmed6807 (NT,SN*) - NeilMed Wound Wash Piercing after care Neilmed6807 (NT,SN*) - Neil Cleanse WoundWash Saline Spray Neilmed6807 (NT,SN*) - NeilCleanse Wash 177 mL Merit1383 (NT,SN) - TruCut 14Ga WilsonWolf3589 (LS,LN*) - G-Rex® 100M-CS Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 100 Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 10 Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 10M Open System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 6 Well Plate WilsonWolf3589 (LS,LN*) - G-Rex® 6M - 2cm2/Well, 6-Well Cell Culture Plate WilsonWolf3589 (LS,LN*) - G-Rex® 10M-CS Closed System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 24 Well Plate WilsonWolf3589 (LS,LN*) - G-Rex® 100M-CS Closed System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 6M - 5cm2/Well, 6-Well Cell Culture Plate WilsonWolf3589 (LS,LN*) - G-Rex® 5M Open System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 100M Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS Cell Culture Product CorningME1979 (CH1) - Corning Polystyrene Microcarrier beads, Corning Synthemax Microcarrier beads WilsonWolf3589 (LS,LN*) - G-Rex® 500M-TF Tissue Fragment, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 500M, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 6M Well Plate WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS, Closed System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS, Closed System, Research Use Only WilsonWolf3589 (LS,LN*) - G-Rex® 50M-TF Research Use Only Carefusion5709 (EP1) - SEC Set 20DP 30IN w/Hanger LL Carefusion (TM) - set, administration, intravascular Carefusion5709 (TM) - Medline IV Admin Set Carefusion (TM) - (NT) - Secondary Set Xenco6850 (NT) - CancelleX™ Cervical Interbody SpineWave3277 (NT) - Leva Ti PF Eagle1350 (NT,SN) - Wrist Fusion Plate Xenco6850 (NT) - CancelleX Porous Titanium Lumbar Interbody Device Merit1383 (NT,SN,TM) - TruCut 18Ga Carefusion (EP1) - SmartSite standalone and extension sets Carefusion5709 (EP1) - Alaris SmartSite Needle-Free Valve Carefusion5709 (TM) - Medline IV Admin Set Carefusion (NT) - set, administration, intravascular LSO2556 (NT) - Spinous Process Plate Xenco6850 (NT) - Cancellex Porous Titanium Lumbar Interbody DermaSci1232 (LN) -MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY Neilmed6807 (NT) - NeilMed Neil Cleanse WoundWash Saline Spray; Carefusion (NT) - set, administration, intravascular Eagle1350 (NT,SN) - Acumed - Bone Graft System Carefusion (NT) - set, blood transfusion SurgicalSpecialties6945 (NT) - Gut Sutures Eagle1350 (NT,SN) - NanoPhix Lag Screw System Eagle1350 (NT,SN) - TiGer Shark™ System Eagle1350 (SN,NT) - Acumed Modular Shoulder System Nobel6405 (NT) - Replace Select Tapered TiU WP 5x10mm Nobel6405 (NT) - Easy Abutment NobRpl Carefusion (NT) - BD Texium™ Needle-Free Syringe Smith&Nephew3754 (NR) - (6) Passing Pins, Drill Tip, 2.7mm x 381mm Smith&Nephew3754 (NR) - 4.5 Incisor S&N3754 (NR) - Drill, 1.6mm and Guide, Dynomite™ 2 Smith&Nephew3754 (NR) - Drill, 2.6mm and Guide, Raptormite™ 3 S&N3754 (NR) - Drill, 3.2mm and Guide, Raptormite™ 3.7 Smith&Nephew3754 (NR) - Drill, 1.8mm and Guide, Spyromite™ / Minitac™2 Wolfmed8101 (MN) - DIAMOND BURR 3MM WL 350MM ROUND Protech3048 (NT) - KMTI Bipolar Hip System Carefusion5709 (NT) - MaxGuard extension set with Y-site(s) Carefusion5709 (NT) - MaxGuard single dose vial access spike Carefusion5709 (NT) - MaxPlus presssure rated extension set with needleless connector and y-site Carefusion5709 (NT) - MaxPlus pressure rated extension set with needleless connector Carefusion5709 (NT) - MaxGuard pressure rated T-connector extension set Carefusion5709 (NT) - MaxGuard Extension Set Carefusion5709 (NT) - MaxPlus, MaxGuard multi-fuse extension set with needleless connector(s) Carefusion5709 (NT) - MaxGuard pressure rated extension set with Y-site(s) Carefusion5709 (NT) - MaxGuard extension set with needleless Y-site(s) Carefusion5709 (NT) - MaxGuard pressure rated T-connector extension set with needleless connector Carefusion5709 (NT) - MaxPlus, MaxGuard pressure rated T-connector extension set with needleless connector Carefusion5709 (NT) - MaxPlus Needleless Connector Carefusion5709 (NT) - MaxGuard, MaxPlus multi-fuse extension set with needleless connector(s) Carefusion5709 (NT) - MaxPlus Extension Set Carefusion5709 (NT) - MaxGuard multi-fuse extension set with needleless connector(s) Carefusion5709 (NT) - MaxGuard pressure rated extension set Carefusion5709 (NT) - MaxGuard T-connector extension set with needleless connector Carefusion5709 (NT) - MaxGuard T-connector extension set Carefusion5709 (NT) - MaxPlus pressure rated extension set with removable needleless connector Carefusion5709 (NT) - MaxGuard, MaxPlus multi-fuse extension set with needleless connector (s) Carefusion5709 (NT) - MaxGuard standard needleless connector Carefusion5709 (NT) - MaxGuard extension set with standard needleless connector Carefusion5709 (NT) - MaxPlus, MaxGuard T-connector extension set with needleless connector Carefusion5709 (NT) - MaxGuard multidose vial adaptor Carefusion5709 (NT) - MaxGuard Extension Set with Filter Carefusion5709 (NT) - MaxPlus extension set with needleless connector and y-site Carefusion (NT) - 96"IV GRAVITY SET W/2 NDL FREE Y SITE Xenco6850 (NT) - Lumbar Interbody System Xenco6850 (NT) - SETx Lumbar Interbody System Xenco6850 (NT) - SET ALIF INSERTER Xenco6850 (NT) - SET PLIF/TLIF/OBLIQUE INSERTER Xenco6850 (NT) - SET TLIF TAMP Xenco6850 (NT) - Xenco Medical Lumbar Interbody System Eagle1350 (NT) - TriMed EOS Small Bone Fixation System -Staples & Pins Nitinol Staple Nobel6405 (NT) - Snappy Abutment Carefusion (NT,TM) - set, administration, intravascular Providien2420 (NT) - Soft K-Rette Kylon Wound Providien2420 (NT) - Soft K-Bride Kylon Wound LSO2556 (NT) - VYCOR VIEWSITE BRAIN ACCESS SYTEM with ALIGNMENT CLIP Desco14244 (NT) - STELLAR Knee StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK-SOFT TISSUE FIXATION StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK BONE-TENDON-BONE BVI1689 (EP1) - CustomEyes Zimmer (LN,LS) - Toggleloc Zimmer (LN,LS) - Maxfire Acuderm1463 (WH,LS) -Acu-Punch Kit SurgicalSpecialties6945 (TM,NT) - Polyester Sutures Amphenol15397 (NT) - ITE transducer array Avanos2508 (EP1,EP2,NT) - MIC PEG TUBE Avanos2508 (EP1,EP2,NT) - MIC PEG Kit Xenco6850 (NT) - SETx Pedicle Screw System Intuitive5779 (NT) - Stapler Sheath LSO2556 (NT) - Filler, Bone Void, Calcium Compound Merit1383 (SN,NT) - PAL - Pen and Labels KeySurgica6941 (LS) - Sterile Labels RMAC1276 (WT) - PharmaTags Eagle1350 (NT,SN) - SLIC Screw BVI1689 (EP1) - Iris Ring BVI1689 (EP1) - Iris Ring & Inserter MicroSurg4751 (BP) - Malyugin RIng SurgicalSpecialties6945 (NT) - Bone Wax Neilmed6807 (NT,SN*) - NasaMist - Isotonic Neilmed6807 (NT) - NeilMed NasaMist Extra Strength (Hypertonic) Saline Spray Neilmed6807 (NT,SN*) - Ultra Gentle Spray Neilmed6807 (NT,SN*) - Walgreen Nasal Mist Neilmed6807 (NT) - Walgreens Nasal Mist Neilmed6807 (NT) - NeilMed SinuHale Carefusion (LS,NT) - SmartSite Stopcock Zimmer (LN,LS) - Bit, drill StrykerPR3324 (GR, LS, VG) - Twinloop FLEX TM Drill StrykerPR3324 (GR, LS, VG) - TwinLoop FLEX Zimmer (LN,LS) - Cannulated toggle button drill 4.5 MM Zimmer (LN,LS) - Maxfire Zimmer (LN,LS) - Toggleloc Eagle1350 (NT,SN) - Drill OmegaSurgical (LSRTC) - BIT, DRILL OrchidUnique5936 (LN) - Bit, Drill - Omega SurgicalSpecialties6945 (NT) - Surgical Knives Carefusion (LS,NT) - Gravity Burette Sets Protech3048 (TM) - Vampiro

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2013-01-29
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2020-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-12-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-13
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2013-02-11
LPZ Container, Frozen Donor Tissue Storage Unknown Class U N/A 2022-12-05
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2013-01-08
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2012-11-16
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2019-12-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-12-04
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-24
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2012-12-19
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2019-12-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2018-12-05
BTX Board, Arm (With Cover), Sterile General, Plastic Surgery Class 1 878.3910 2023-01-24
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2017-07-06
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2013-01-07
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-01-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-07-01
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-24
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2014-06-17
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-23
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2012-12-20
KNY Accessories, Catheter, G-U Gastroenterology, Urology Class 2 876.5130 2024-05-20
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2024-05-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2001-08-06
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2012-12-18
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2017-03-13
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2012-12-20
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2019-12-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-13
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2017-12-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-12-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-05
HEW Culdoscope (And Accessories) Obstetrics/Gynecology Class 2 884.1640 2019-09-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
JEY Plate, Bone Dental Class 2 872.4760 2012-11-14
QGZ Electrical Tumor Treatment Fields Unknown Class 3 N/A 2023-04-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-30
FER Anoscope And Accessories Gastroenterology, Urology Class 2 876.1500 2017-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-13
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2025-12-10
HGP Electrode, Circular (Spiral), Scalp And Applicator Obstetrics/Gynecology Class 2 884.2675 2012-12-20
QBP Cap, Device Disinfectant General Hospital Class 2 880.5440 2017-01-04
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-12-05
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2024-05-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-13
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2017-12-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2017-12-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2013-02-11
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2012-12-27
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2025-12-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-10-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-09-10
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2012-12-20
LRN Wire, Surgical Orthopedic Class 2 888.3030 2012-12-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-12-18
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-07-06
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2012-12-20
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2020-10-09
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-01-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-06-30
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-11-27
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-03
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2012-12-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-01-23
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2012-12-28
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-06-23
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-06-23
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-08-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-08-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2012-12-27
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2012-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 2014-04-01
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2012-11-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-03-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2014-03-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2018-12-02
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2019-11-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-29
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-25
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2020-01-23
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2012-12-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-12-20
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2014-04-08
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2015-07-17
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2015-07-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-13
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-27
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-24
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2015-02-19
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2017-09-14
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-11-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-05
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2020-10-22
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2018-12-02
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2018-12-02
FCY Bulb, Inflation, For Endoscope Gastroenterology, Urology Class 1 876.1500 2023-07-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-13
NZK Stimulator, Low Electric Field, Tumor Treatment Unknown Class 3 N/A 2023-02-16
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2020-01-23
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-03-14
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2012-11-14
LZU Plug, Punctum Unknown Class U N/A 2013-01-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-08-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-10-27
PHQ Anterior Staple As Supplemental Fixation For Fusion Orthopedic Class 2 888.3060 2023-06-23
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2013-02-11
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2025-11-21
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2026-03-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-12-20
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2016-05-19
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2016-11-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-11-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-11-22
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2016-11-22
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2012-12-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-12-26
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2022-12-26
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2022-12-26
GAL Suture, Absorbable, Natural General, Plastic Surgery Class 2 878.4830 2022-12-26
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2022-12-26
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-12-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-12-20
FEN Device, Cystometric, Hydraulic Gastroenterology, Urology Class 2 876.1620 2012-12-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-10
OAO Cord Blood Processing System And Storage Container Hematology Class 2 864.9900 2020-11-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2020-11-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-11-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-13
LZU Plug, Punctum Unknown Class U N/A 2018-04-18
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2024-12-04
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-12-04
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-12-04
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-22
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2018-12-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2025-08-28
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2025-08-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-01-26
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2019-11-21
KJF System, Suspension, Cell Culture Hematology Class 1 864.2240 2013-12-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2014-03-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-03-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-06-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-25
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2024-01-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
LPZ Container, Frozen Donor Tissue Storage Unknown Class U N/A 2019-11-11
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2016-11-22
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-07-06
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-07-06
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2012-12-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-01-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2020-10-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-04
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2019-11-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2024-09-23
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2013-01-30
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat Class 2 874.3620 2013-01-30
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2013-01-30
HWQ Passer Orthopedic Class 1 888.4540 2013-01-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-04
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-01-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2012-12-20
BRZ Set, Blood Transfusion General Hospital Class 2 880.5440 2014-09-25
GAL Suture, Absorbable, Natural General, Plastic Surgery Class 2 878.4830 2012-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-10
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-05
GXL Screwdriver, Skullplate Neurology Class 1 882.4900 2022-11-11
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2025-08-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-08-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-12-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2012-12-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-01-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-06-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-11-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-03-10
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2021-08-26
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2021-08-26
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2021-08-26
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2021-08-26
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-14
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2024-03-14
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-03-14
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2012-12-27
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2012-12-27
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2023-06-23
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2022-07-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-03-24
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2014-03-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2018-06-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-06-15
FIE Needle, Fistula Gastroenterology, Urology Class 2 876.5540 2026-03-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-11-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-14
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-11-14
HDB Extractor, Vacuum, Fetal Obstetrics/Gynecology Class 2 884.4340 2012-12-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2024-07-18
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2021-01-26
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2015-02-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2018-06-12
SBF Orthopedic Augmented Reality Neurology Class 2 882.4560 2025-12-02
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-12-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2018-12-02
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2012-12-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-30
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2012-12-18
SDA Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer Unknown Class 3 N/A 2025-08-28
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2023-01-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-13
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2012-10-31
HFN Transducer, Pressure, Intrauterine Obstetrics/Gynecology Class 2 884.2700 2012-12-20
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2017-12-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-12-13
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2018-06-07
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2013-02-11
DZI Drill, Bone, Powered Dental Class 2 872.4120 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-12-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-12-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-12-04
OJK Eye Tray Ophthalmic Class 2 886.4790 2013-01-28
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2024-02-12
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2013-01-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-12-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2017-12-13
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2026-03-05
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2026-03-05
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2024-07-08
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-06-18
LZU Plug, Punctum Unknown Class U N/A 2022-01-11
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2019-11-15
GEE Brush, Biopsy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-12-03
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2012-11-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-05-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-03-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-03-24
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-03-24
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-03-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-03-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-30
KPE Container, I.V. General Hospital Class 2 880.5025 2022-02-03
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2015-07-17
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2012-11-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
DZI Drill, Bone, Powered Dental Class 2 872.4120 2024-05-17
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2013-01-29
HOC Clip, Iris Retractor Ophthalmic Class 1 886.4350 2012-12-28
MTJ Wax, Bone Unknown Class U N/A 2012-12-18
KCO Nasal Spray, Ent Delivery Ear, Nose, Throat Class 1 874.5220 2021-12-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-13
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2013-01-29
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2014-09-25
FDT Duodenoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-10-17
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2012-12-27
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-04-19
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2012-12-27
HTW Bit, Drill Orthopedic Class 1 888.4540 2012-12-27
FRN Pump, Infusion General Hospital Class 2 880.5725 2024-09-16
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2023-05-04
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2023-04-10
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2020-01-23
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2017-12-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2012-12-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018811167 MEDIVATORS INC Rogers, MN, US
3038285067 Synergy Sterilisation Kulim (M) Sdn. Bhd Seberang Perai Selatan Pulau Pinang, MY
3031571464 Herotron E-Beam Service GmbH Bitterfeld Saxony-Anhalt, DE
3010897183 Synergy Health Marseille SAS CHUSCLAN Gard, FR
3008252486 ELECTRON BEAM SDN BHD Port Klang Selangor, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K811830 Cordis Corp. C-DAK DUO-FLUX ARTIFICIAL KIDNEY 1981-09-21
K070320 Edwards Lifesciences Services GmbH EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 2007-06-07
K150880 Outset Medical Tablo Console with Wireless Capability 2015-05-01
K220566 Koag, LLC Vascette HP (hemostatic pad) 2022-07-29
K080818 Hem Con Medical Technologies, Inc. HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING 2008-05-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0019-2025 Outset Medical, Inc. 2
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis SYS, with CDX
Z-0029-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System without CDX
Z-0030-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System w/Bibag
Z-0031-2024 Fresenius Medical Care Holdings, Inc. 2
2008T GEN 2 Bibag without CDX

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032098. Last updated year: 2026. Please use registration number 2032098 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
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