ISOMEDIX OPERATIONS INC.

FDA Device Registration & Listing · Sandy, UT, US · Registration 1720929

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
1720929
FEI Number
1720929
Entity Name
ISOMEDIX OPERATIONS INC.
City/State/Country
Sandy, UT, US
Establishment Address
9120 SOUTH 150 EAST, Sandy, UT 84070, 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

MegaDyne1382 (SN) - MegaTip Eagle1350 (NT,SN) - External Fixator 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 Ortho1399 (SN,EP1*) - Ortho Development Balanced Knee System Eagle1350 (NT,SN) - Bone Plate System Eagle1350 (NT,SN) - Octane PEEK Vertebral Body Replacement Ortho1399 (SN,EP1) - Primaloc Cemented Hip System Ortho1399 (SN),EP1* - Ortho Development Balanced Knee System Merit1383 (SN) - 1ml Syringe Eagle1350 (NT,SN) - Wrist Fusion Plate Merit1383 (SN) - ShortStop Temporary Sharps Holder Merit1383 (TM) - BackStop Plus Closed Waste Basin Merit1383 (SN) - ShortStop Advantage Temporary Sharps Holder Merit1383 (NT,SN) - ShortStop Advantage Temporary Sharps Holder Ranfac3098 (NR) - SS-1529, Hypodermic Needle, S-115 BVI1689 (CH1,EP1) - Retrobulbar BVI1689 (EP1, CH1) - Peribulbar Clearside6394 (MN,SP) - SCS Microinjector Depuy (NR) - CELLECT BONE MARRO; CONFIDENCE SPINAL CEMENT SYSTEM Ortho1399 (SN,EP1) - 10x17 and 12x17 Extended Stems Ortho1399 (SN,EP1) - Encompass Press-fit Hip Stem Eagle1350 (NT,SN) - Bone Screw 3.5mm MegaDyne1382 (SN) - Megadyne EZ clean electrosurgical pencil Merit1383 (NT,SN) - TruCut 14Ga Acumed4864 (SN,NT) - Acumed Clavicle Hook Plate Eagle1350 (NT,SN) - External Fixator Merit1383 (SN,NT) - PAL - Pen and Labels KeySurgica6941 (LS) - Sterile Labels RMAC1276 (WT) - PharmaTags Eagle1350 (NT,SN) - Polarus Cap Screw Ortho1399 (SN,EP1) - Balanced Knee Tibial Tray Pegged Eagle1350 (NT,SN) - NanoPhix Lag Screw System Ortho1399 (SN,EP1*) - Ortho Development Balanced Knee System Eagle1350 (NT) - TriMed EOS Small Bone Fixation System -Staples & Pins Nitinol Staple Eagle1350 (NT,SN) - Trimed Nitinol Staple System MML1375 (SN) - HemoBand HB-1M Zimmer (LN) - PRECISION FLX RMR 5MM DISP Zimmer (LN)- PRECISION FLX RMR 5.5MM DISP Zimmer (LN) - precision flexible reamer disposable 9.5mm Zimmer (LN) - precision flexible reamer disposable 12mm Zimmer (LN) - precision flexible reamer disposable 4.5mm Zimmer (LN) - precision flexible reamer disposable 11mm Zimmer (LN) - precision flexible reamer disposable 7.5mm Zimmer (LN) - precision flexible reamer disposable 8mm Zimmer (LN)- PRECISION FLX RMR 6MM DISP Zimmer (LN) - precision flexible reamer disposable 9mm Zimmer (LN) - precision flexible reamer disposable 11.5mm Zimmer (LN) - precision flexible reamer disposable 7mm Zimmer (LN) - precision flexible reamer disposable 10.5mm Zimmer (LN) - PRECISION FLX RMR 6.5MM DISP Zimmer (LN) - precision flexible reamer disposable 8.5mm Zimmer (LN, LS) - Trauma Fixation Systems Zimmer (LN) - precision flexible reamer disposable 10mm Viant8257 (NR,WH*) - Reamer Eagle1350 (NT,SN) - Silverbolt MIS Mainframe HA Screw System Nexus8199 (SN) - Tranquil Ortho1399 (SN,EP1) - Balanced Knee System Revision Offset Tibia Nexus8199 (SN) - Nexus Spine Ortho1399 (SN,EP1*) - Ortho Development Balanced Knee System Merit1383 (SN) - SafeGuard Focus Compression Eagle1350 (NT,SN) - Osteo-Clage Cerclage Cable System HealthLineInt6565 (SN) - DualCap IV Pole Strips Ortho1399 (SN,EP1) - Balanced Knee System Nexus8199 (SN) - Nexus Spine Nexus8199 (SN) - PressON Zimmer (LN, LS) - Trauma Fixation Systems Zimmer (LN, LS) - Nail Extractor Tap, Trauma Fixation Systems Zimmer (LN,LS) - Maxfire Nexus8199 (SN) - Stable Terumo2207 (SN,LN) - COBE 2991 cell processor Eagle1350 (NT,SN) - Acumed Anatomic Radial Head Merit1383 (NT,SN,TM) - TruCut 18Ga Protech3048 (NT) - BonVie+ Eagle1350 (SN,NT) - Bulb & Bladder MegaDyne1382 (SN) - E-Z Clean MML1375 (SN) - Meridian Viral Transport Carefusion (EP1,SN,LS,NT) - Secondary Sets with Shrouded Needle Eagle1350 (NT,SN) - SLIC Screw Eagle1350 (NT,SN) - Depth Gauge Merit1383 (SN,NT) - Safeguard Pressure Assisted Device 24 cm Eagle1350 (NT,SN) - Acutrak Plus Fixation System Ortho1399 (SN,EP1) - Contour Spinal System Ortho1399 (SN,LN*) - Ortho Development Balanced Knee System Eagle1350 (NT,SN) - INNate 3.6 system 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 Ortho1399 (SN,EP1) - Balanced Knee System Ultracongruent Tibial Insert Eagle1350 (NT,SN) - Orthopaedic Wires Ortho1399 (SN,EP1) - Balanced Knee System Modular Revision Knee System Ortho1399 (SN,EP1) - Ceramic Femoral Heads Ortho1399 (SN,EP1) - Entrada Hip Stem Eagle1350 (NT,SN) - InFrame System Eagle1350 (NT,SN) - Blackhawk Cervical Spacer System Merit1383 (SN) - K01 Syringe Kit (10mL COP) Eagle1350 (NT,SN) - Acutrak Ortho1399 (SN,EP1) - Encompass Cemented Hip System Ortho1399 (SN,EP1) - Envision Anterior Cervical Plate System Sanuwave (LN,LS,SN) - UltraMIST Eagle1350 (NT,SN) - Cannulated Cancellous Bone Screw MML1375 (SN) - MML Specimen Collection Swab Ensera7760 (GR,SP) - Sterile Flocked Swab Ensera7760 (GR,SP) - SteriPack Sterile Polyester Spun Swab Ensera7760 (LN,SP) - Sterile 3" Foam Swab with yellow handle v2 Puritan5503 (NR) - CaligSwab; HydraFlock; PurFlock Ultra; Puritan, Pur-Wraps; PurSwab SteriPackUSA7760 (SP) - Sterile Foam Swab with yellow handle Puritan5503 (NR) - Sterile Foam Tipped Applicator Puritan5503 (NR) - Hospital, Sterile Cotton Tipped Applicators Robling1585 (SP) - ClearTip Swab Ultra Thin Birchwood1772 (MN) - Scopettes JR Puritan5503 (NR) - Sterile Cotton Tipped Applicators Puritan5503 (NR) - Puritan, Sterile Polyester Tipped Applicators Nexus8199 (SN) - Tranquil Nexus8199 (SN) - Nexus Spine Eagle1350 (NT,SN) - TiGer Shark™ System Merit1383 (SN) - DualCap Merit1383 (SN) - DualCap Solo Merit1383 (SN) - DualCap IV Pole Strips Merit1383 (SN) - Dark Blue Cap for Male Luers HealthLineInt6565 (SN) - DUALCAP SOLO Ortho1399 (SN,EP1*) - Ortho Development Balanced Knee System StrykerNeuro6283 (SN,LN) - Synchro- 14 Guidewire Eagle1350 (NT,SN) - Acumed Scapula Congruent Bone Plate Eagle1350 (NT,SN) - Octane Straight Intervertebral Fusion Device, Ti Coated Merit1383 (SN, NT) - Medallion Syringe Merit1383 (SN, NT) - K01 Syringe Kit (MSS) Eagle1350 (SN,NT) - Acumed Modular Shoulder System MegaDyne1382 (SN) - Stainless Steel Electrodes Ortho1399 (SN,EP1) - Headloc Alumina and Zirconia Ceramic Heads 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 Carefusion (EP1,SN,LS,NT) - PrimeSaver Sets (Ball Valve) Eagle1350 (NT,SN) - Cortical Bone Screw Carefusion (EP1) - Gemini/Alaris Pump Module sets Carefusion5709 (EP1) - Alaris Pump Module SmartSite Low Sorbing Infusion Set Carefusion (NT) - set, administration, intravascular MegaDyne1382 (SN) - Megadyne Laparoscopic Tubing Ortho1399 (SN,EP1) - Vusion PEEK VBR System Merit1383 (TM) - Worley Slitter Merit1383 (TM) - Transavalvular Insertion tool (TVI) Merit1383 (TM) - Contamination Sleeve Protech3048 (TM) - Helix Locking Tool (HLT), Model A001HELX HealthLineInt6565 (SN) - DUALCAP SOLO Ortho1399 (SN,EP1) - ODC B2 Bipolar Cup 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 HealthLineInt6565 (SN) - DUALCAP SOLO Eagle1350 (NT,SN) - Cerclage Wire Crimp Sleeve Ortho1399 (SN,EP1) - Legend All-poly Cup Merit1383 (SN,NT) - Safeguard Radial Compression Device PFMMedical6614 (TM) - ASEPT Procedure Pack (Ref M7040) Merit1383 (SN, NT) - K13 Label Kit PFMMedical6614 (TM) - Jet-Vac Ortho1399 (SN,EP1) - Biolox Delta Ceramic Femoral Heads Ortho1399 (SN,EP1*) - Ortho Development Balanced Knee System Biomerics6631 (SN) - Amedica Valeo II Interbody Fusion Device Eagle1350 (NT,SN) - Octane PEEK Vertebral Body Replacement GenSee1356 (SN) - Cardiac Insulator 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) - Congruent Bone Plate System Ortho1399 (SN,EP1) - Primaloc Cementless Hip System Nexus8199 (SN) - Tranquil Zimmer Biomet (LS) - HydroDam Cannula System Zimmer (LS) - HydroDam Cannula System Ortho1399 (SN,EP1) - Escalade Acetabular Cup System StrykerNeuro6283 (SN,LN) - Synchro- 10 Guidewire Ortho1399 (SN,EP1) - Pivot Bipolar Head Eagle1350 (NT,SN) - Ascendant Cervical Spacer System Eagle1350 (NT,SN) - Acumed - Tension Band Pin 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 MML1375 (SN) - Pro-lab Amnio Test GenSee1356 (SN) - Anastomark Flexible Coronary Bypass Graft Eagle1350 (NT,SN) - Guide Wire Ortho1399 (SN,EP1) - Headloc Zirconia Ceramic Femoral Heads MegaDyne1382 (SN) - Lletz Loop Electrodes HandBio1360 (SN) - PIP Fix 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 Nexus8199 (SN) - PressON Ortho1399 (SN,EP1) - Balanced Knee Modular Tibial System Nexus8199 (SN) - Nexus Spine Ortho1399 (SN,EP1) - Solitude Unipolar Head Ortho1399 (SN, EP1*) - Ibis Pedicle Screw System Nexus8199 (SN) - Nexus Spine MegaDyne1382 (SN) - E-Z Clean Laparoscopic Electrodes Lifecycle4797 (SN) - EasiSlush Relievant11933 (LN,SN,GR) - Intracept System - Access Instruments Nexus8199 (SN) - PressON Nexus8199 (SN) - Tranquil Ortho1399 (SN,EP1) - ISS Integrated Spine System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-09
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2012-12-20
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-11-21
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-01-26
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2015-02-02
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2015-02-02
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2015-02-02
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2021-02-18
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2012-12-18
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-11-21
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-10-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-12-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-12-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-17
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2023-11-14
DTI Sizer, Heart-Valve, Prosthesis Cardiovascular Class 1 870.3945 2023-11-14
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2012-12-19
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-28
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2022-10-20
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2018-10-21
FMF Syringe, Piston General Hospital Class 2 880.5860 2026-01-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2012-11-07
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2012-12-19
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2012-12-19
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2012-11-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-09
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2019-11-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-29
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2012-12-20
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2012-11-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-12-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-02-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-02-06
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2020-02-06
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2018-05-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-05-08
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2018-05-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-05-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2012-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-11-21
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
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2026-03-24
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-05-08
HTO Reamer Orthopedic Class 1 888.4540 2013-01-07
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2012-12-18
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2012-12-18
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2012-12-18
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2018-12-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-10-17
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-19
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-12-01
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-12-01
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2017-07-06
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-11-21
MHW Dressing, Compression General Hospital Class 1 880.5075 2020-09-10
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2012-12-20
DTI Sizer, Heart-Valve, Prosthesis Cardiovascular Class 1 870.3945 2025-11-24
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2025-11-24
QBP Cap, Device Disinfectant General Hospital Class 2 880.5440 2017-03-08
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2022-10-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2022-10-17
HWX Tap, Bone Orthopedic Class 1 888.4540 2018-01-22
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2022-09-15
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2023-11-14
GED Brush, Dermabrasion, Manual General, Plastic Surgery Class 1 878.4800 2022-08-06
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-10-17
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2012-10-18
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2012-12-20
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2019-11-21
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2013-02-11
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-18
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2025-03-26
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2020-10-26
FCY Bulb, Inflation, For Endoscope Gastroenterology, Urology Class 1 876.1500 2023-07-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-09
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2012-12-17
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2018-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2017-01-03
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
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2020-10-23
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2012-12-18
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2023-11-14
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-02-18
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-02-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2012-11-09
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-05-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-13
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-01-13
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2020-10-26
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-05-08
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2012-11-08
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-02-18
HFN Transducer, Pressure, Intrauterine Obstetrics/Gynecology Class 2 884.2700 2012-12-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2012-11-19
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2012-11-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-11-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-02-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-10
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-19
LRN Wire, Surgical Orthopedic Class 2 888.3030 2012-12-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-19
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-12-05
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2017-12-18
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2017-12-18
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2017-12-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-10
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2018-12-05
FMF Syringe, Piston General Hospital Class 2 880.5860 2026-01-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-19
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-12-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2012-12-19
NRB Wound Cleaner, Ultrasound General, Plastic Surgery Class 2 878.4410 2014-11-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2012-11-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-10-17
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-12-01
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2023-01-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-05
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2012-12-18
QBP Cap, Device Disinfectant General Hospital Class 2 880.5440 2017-03-08
QBP Cap, Device Disinfectant General Hospital Class 2 880.5440 2017-01-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-11-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-09-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
KCN Ear Wick Ear, Nose, Throat Class 1 874.5220 2012-12-27
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2024-12-17
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-12-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-05
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2012-12-18
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-09-15
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2012-12-18
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2012-12-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-09
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2012-12-27
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
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2024-12-17
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2024-12-17
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2024-12-17
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2024-12-17
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-12-17
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
FCZ Tube, Smoke Removal, Endoscopic Gastroenterology, Urology Class 1 876.1500 2012-12-27
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-09-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-12-19
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2012-12-27
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2015-12-21
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-02-18
QBP Cap, Device Disinfectant General Hospital Class 2 880.5440 2014-09-25
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-02-06
DWC Controller, Temperature, Cardiopulmonary Bypass Cardiovascular Class 2 870.4250 2012-12-18
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2017-12-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-12-15
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2017-12-15
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2017-12-15
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2017-12-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2017-12-15
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2012-12-19
HTW Bit, Drill Orthopedic Class 1 888.4540 2012-12-27
FQM Bandage, Elastic General Hospital Class 1 880.5075 1994-04-11
QBP Cap, Device Disinfectant General Hospital Class 2 880.5440 2014-09-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2012-12-20
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2012-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2012-12-19
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2015-07-10
PYB Minor Surgical Procedures Tray General, Plastic Surgery Class 1 878.4800 2020-03-12
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-11-21
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2012-12-20
OJK Eye Tray Ophthalmic Class 2 886.4790 2013-01-28
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-02-18
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-02-18
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2021-02-18
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2021-02-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-02-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-03
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-14
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
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2018-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-12-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-12-19
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-02-01
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2012-12-27
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2013-02-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2012-12-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-10-17
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2012-12-27
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2012-12-19
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2016-05-31
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-02-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-02-02
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2015-12-07
NXH Nursing Pad, Cohesive Gel General Hospital Class 1 880.5630 2022-09-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-02-18
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-09-02
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2012-12-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2012-12-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-28
PEH Hemodialysis Catheter Luer End Cap Gastroenterology, Urology Class 2 876.5540 2020-01-30
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2024-09-11
NQM Immunoassay For Detection Of Amniotic Fluid Protein(S). Clinical Chemistry Class 1 862.1550 2024-09-11
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-12-05
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2015-02-02
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2015-02-02
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2015-02-02
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2015-02-02
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-12-20
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2012-11-16
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2012-12-17
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2012-12-18
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2017-03-13
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2022-08-18
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2012-11-09
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2021-12-09
KCO Nasal Spray, Ent Delivery Ear, Nose, Throat Class 1 874.5220 2021-12-02
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-10-17
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2025-11-21
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-19
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2024-12-17
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2024-12-18
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-12-18
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2024-12-18
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-12-01
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2013-01-30
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2012-12-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-06-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-06-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-06-21
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-12-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-09
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2024-03-20
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2018-12-19
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2018-12-19
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2018-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-12-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-12-19
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-27
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2023-07-06
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-10-31
QGI Air-Handling Apparatus Accessory General, Plastic Surgery Class 1 878.5080 2026-05-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2022-10-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-10-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-19

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
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0001-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1720929. Last updated year: 2026. Please use registration number 1720929 when referencing this establishment in official correspondence.
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