Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1526711

FEI Number

1526711

Entity Name

ISOMEDIX OPERATIONS INC

City/State/Country

GROVEPORT, OH, US

Establishment Address

4405 MARKETING PLACE, GROVEPORT, OH 43125, 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

StrykerPR3324 (GR, LS) - 8 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 6.5mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5mm X 90mm Threaded Cannula StrykerPR3324 (GR, LS, VG) - CANNULA PLUG StrykerPR3324 (GR, LS) - 5 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 6.5mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 8mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 5mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 8mm X 90mm Threaded Cannula StrykerPR3324 (GR, LS) - 5mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 8 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 5 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 8mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 5mm X 90mm Threaded Cannula Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 45mm Threaded Smith&Nephew3754 (NR) - CLEAR-TRAC Disposable Scope/Shaver Cannula, with Distal Rib Smith&Nephew3754 (NR) - Fixation Post, 5mm x 30mm Smith&Nephew3754 (NR) - DISP KNIFE ROSSETTE 3MM STR(5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 7mm x 72mm, Threaded Smith&Nephew3754 (NR) - SUTURE Threaders Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 45mm, Threaded Smith&Nephew3754 (NR) - ACUFEX Clear.Trac Threadedd.10 IDx76 LTX(10) Smith&Nephew3754 (NR) - DISPOSABLE KNIFE V SHAPED Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 35mm Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 8mm LTX Free (10) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 6.5 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 90mm, Threaded Smith&Nephew3754 (NR) - DISPOSABLE KNIFE HOOK 3MM (5) Smith&Nephew3754 (NR) - Split Cannula Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 4.5mm x 72mm, Threaded Smith&Nephew3754 (NR) - CLEAR-TRAC Disposable Scope/Shaver Cannula, Smooth Smith&Nephew3754 (NR) - TRANSPORTER (BOX 4) STERILE Smith&Nephew3754 (NR) - Clear-Trac Thrd Cann 5mm/76mm LTX Free (10) B Smith&Nephew3754 (NR) - Endoscopic Cann.Drill.Bit 4.5mm Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 90mm Threaded Smith&Nephew3754 (NR) - Fixation Post, 5mm x 40mm Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 6.5 x 72mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 7mm x 72mm, Smooth Smith&Nephew3754 (NR) - Univ Cannula 5mm/76mm LTX Free (10) Blue Smith&Nephew3754 (NR) - 3.8mm Tapered Awl, Disposable Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 9mm LTX Free (10) Smith&Nephew3754 (NR) - DISPOSABLE KNIFE SERRATED (5) Smith&Nephew3754 (NR) - PCL Safety Guidewire, 2.4mm x 25cm Smith&Nephew3754 (NR) - Guide Wire, 1.2mm x 12 (Box 5) Smith&Nephew3754 (NR) - Guide Wire, 1.2mm x 9 (Box 5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 4.5 x 72mm Threaded Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 30mm Smith&Nephew3754 (NR) - MENISCUS MENDER II DISPOSABLE Smith&Nephew3754 (NR) - Clear-Trac Complete Hip Cannula Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 5.5mm x 45mm, Threaded Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 7mm LTX Free (10) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 55mm Threaded Smith&Nephew3754 (NR) - DISPOSABLE KNIFE SHARP TIP Smith&Nephew3754 (NR) - Flexible Passing Pin, 13.50 X 2.4mm (Qty 5) Smith&Nephew3754 (NR) - SUTURE PASSER 2 STERILE Smith&Nephew3754 (NR) - Passing Pin, Drill Tip, 2.4mm x 15 Smith&Nephew3754 (NR) - DISP KNIFE SERRATED FLAT(BX 5) Smith&Nephew3754 (NR) - Clear-Trac Threaded Cann 8mm/76mm LTX Free (10) G Smith&Nephew3754 (NR) - (6) Guidewire 2mm x 15 Smith&Nephew3754 (NR) - Univ Cannula 7mm/76mm LTX Free (10) Green Smith&Nephew3754 (NR) - (5) Guidewire, 1.2mmx 18 (46 cm) Smith&Nephew3754 (NR) - Fixation Post, 5mm x 35mm Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 25mm Smith&Nephew3754 (NR) - SUTURE PASSER 12 STERILE Smith&Nephew3754 (NR) BONE TUNNEL PLUG CANN 7-12MM LTX FREE (6 Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 72mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 72mm, Threaded Smith&Nephew3754 (NR) - Fixation Post, 5mm x 25mm Smith&Nephew3754 (NR) - Clear-Trac Complete Stopcock Valve Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 40mm Smith&Nephew3754 (NR) - DISP KNIFE ROUND TIP (BX 5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 55mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 5.5mm x 72mm, Threaded Conmed (SX) - FENESTRATED CANNULA 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 JPac9784 (GR,NR) - LevaLap Laparoscopic Access Device Core11321 (GR,LN*) - LevaLap Atricure2121 (GR,LN*,LS*) - EPi-Ease Epicardial Access Device (EAS) StrykerPR3324 (GR, VG) - StrykerFlow suction Irrigator Relievant11933 (LN,SN,GR) - Intracept System - Access Instruments Haemonetics (GR) - NexSys PCS Aquabiliti1563 (SP,GR) - Saline, vascular access flush StrykerPR3324 (GR, LS, VG) - 10 G Bone Biopsy kit StrykerPR3324 (GR, LS, VG) - iVAS Bone Biopsy Kit 10G, 11G, 13G StrykerPR3324 (GR) - 10 G Bone Biopsy kit StrykerPR3324 (GR,VG) - 8 Gauge Biopsy StrykerPR3324 (GR,VG) - 13G Bone Biopsy Kit StrykerPR3324 (GR,VG) - 9" 10G Bone Biopsy Kit StrykerPR3324 (GR, LS, VG) - 11G Bone Biopsy Kit StrykerPR3324 (GR,VG) - 10G Biopsy Kit Bayer1675 (GR) -[Mark 7 Arterion Injection System] MEDRAD Mark 7 Arterion Disposable Syinge 150mL with Quick Fill Tube Bayer1675 (GR) - [Spectris Solaris EP MR Injector System] Saline Syringe & Tubing for MR Injector System 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 Atricure2121 (GR,LN*,LS*) - cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L) Atricure2121 (GR,LN*,LS*) - cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX) Atricure2121 (GR,LN*,LS*) - cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) Atricure2121 (GR,LN*,LS*) - cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) 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 / Minitac2 Wolfmed8101 (MN) - DIAMOND BURR 3MM WL 350MM ROUND Ecomed7308 (LN) - Sureglide LSO2556 (NT) - C Safe Zimmer (LN) - Carpal Tunnel Release Instruments Zimmer (LN) - ACL GUIDE WIRE DISP KIT Zimmer (LN) - K-WIRE 0.45 (1.1MM) X 9'' PARTIALLY THREADED Zimmer (LN,LS) - Maxfire Atricure2121 (GR) - Atricure - Gillinov-Cosgrove Selection Guide OmegaSurgical (LSRTC) - Guide, surgical, instrument StrykerSustainability (GR) - Remanufactured LigaSure Exact Dissector, Without Nano-coating Atricure2121 (GR,LN*,LS*) - AtriClip PRO-Mini LAA Exclusion System (PROM) StrykerPR3324 (GR, VG) - 2.5mm AGGRESSIVE BLADE 11cm StrykerPR3324 (GR, VG) - 4mm ANGLED AGGRESSIVE 60 DEG Stryker Puerto Rico - 4MM 40 DEG. AGG SERR BLADE StrykerPR3324 (GR, VG) - 3.5mm JAGUAR BLADE StrykerPR3324 (GR, VG) - 4MM 60 DEG. AGG SERR BLADE StrykerPR324 (GR, VG) - 3.5mm 40 Deg. Agg. Serrated StrykerPR 3324 (GR, VG) - 4mm AGGRESSIVE SERRATE StrykerPR3324 (GR, VG - 3.5mm 40 Degree Angled Aggressive Serrated Blade StrykerPR3324 (GR, VG) - 4mm 60 Degree Angle Aggressive Balde StrykerPR3324 (GR, VG) - 4mm JAGUAR BLADE StrykerPR3324 (GR, VG) - 3mm ROUND BUR StrykerPR3324 (GR, VG) - 4mm ANGLED AGGRESSIVE 40 DEG Stryker Puerto Rico - 4mm AGGRESSIVE BLADE StrykerPR3324 (GR, VG) - 4mm Angle Aggressive Blade StrykerPR3324 (GR, VG) - 3.5mm Jaguar Blade StrykerPR3324 (GR, VG) - 3.5mm 60 Degree Angled Aggressive Serrated Blade StrykerPR3324 (GR, VG) - 4mm Aggressive Blade StrykerPR3324 (GR, VG) - 4mm Aggressive Blade 11CM StrykerPR3324 (GR, VG) - 4mm SHARPEDGE BLADE Stryker3324 (GR) - 4mm Jaguar Blade StrykerPR3324 (GR, VG) - 3.5mm Aggressive Blade Stryker Puerto Rico - 2mm ROUND BUR StrykerPR3324 (GR) - 4MM 60 DEG. AGG SERR BLADE StrykerPR3324 (GR, VG) - 4MM 40 DEG. AGG SERR BLADE StrykerPR3324 (GR, VG) - 2.5mm Aggressive Blade Stryker3324 (GR) - 3mm Round Bur StrykerPR3324 (GR, LS) - 4mm Agle Aggressive Blade StrykerPR3324 (GR, VG) - 3.5mm Aggressive Serrated StrykerPR3324 (GR, VG) - 4mm Sharpedge Stryker3324 (GR) - 3.5mm 60 Degree Angle Aggressive Serrated Blade StrykerPR3324 (GR, VG) - iVAS Bone Biopsy Kit 10G, 11G, 13G StrykerPR3324 (GR, LS, VG) - Krackow Press. CRBard4757 (EP1) - Site Scrub OmegaSurgical (LSRTC) - BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Zimmer (LN) - blade, saw, general and plastic surgery, surgical StrykerPR3324 (GR, LS, VG) - PKG ,ENT IRR.AGG.SHAVER BLADE StrykerPR3324 (GR, LS, VG) - SJ Cutter Mnscs StrykerPR3324 (GR, LS, VG) - Cutter Meniscus StrykerPR3324 (GR) - 4 mm ENT MicroDebrider AGGRESSIVE SERRATED StrykerPR3324 (GR, LS, VG) - Cutter Full Radius StrykerPR3324 (GR, LS, VG) - Bur TMJ 2mm StrykerPR3324 (GR, LS, VG) - Bur TMJ 3mm StrykerPR3324 (GR, LS, VG) - SJ Cutter StrykerPR3324 (GR, LS) - 4mm Aggressive Serrated StrykerPR3324 (GR, LS, VG) - SHARPEDGE SHAVER BLADE 4MM StrykerPR3324 (VG) - Full Radius Cutter, Arthroscopic Shaver Blade StrykerPR3324 (VG) - Hooded Abrasion Bur, Arthroscopic Shaver Blade StrykerPR3324 (VG) - Aggressive Cutter, Arthroscopic Shaver Blade OrchidUnique5936 (LN) - Blade, Saw, General & Plastic Surgery, Surgical - Signature Series UltraLite DVL-op6436 (TM) - Motiva Channel Separator 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 StrykerPR3324 (GR, VG) - AHTO SUCTION/IRRIGATION DUAL SPIKE TUBE SET StrykerPR3324 (GR, VG) - STRYKEFLOW2 WITH DISPOSABLE TIP (6BX) StrykerPR3324 (GR, VG) - PKG.SINUFLOW SUCTION/IRRIGATOR StrykerPR3324 (GR, VG) - AHTO SUCTION/IRRIGATION TUBE SET (6BX) StrykerPR3324 (GR, VG) - AHTO SUCTION/IRRIGATION TUBE SET WITH DISPOSABLE TIP (6BX) StrykerPR3324 (GR) - ReelX STT 4.5mm Knotless Anchor StrykerPR3324 (GR, VG) - Omega PEEK Knotless Anchor System StrykerPR3324 (GR, VG) - OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, SINGLE StrykerSustainability (GR) - Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider Atricure2121 (GR, LN*,LS*) - AtriCure cryoICE cryoXT cryoablation probe (cryoXT) Bayer1675 (GR) - [Mark 7 Arterion Injection System] MEDRAD Mark 7 Arterion Disposable Syinge 150mL with Quick Fill Tube Globus4330 (GR,NT*) - NuVasive NVJJB System Medline (GR,LN) - Medline Protech3048 (TM) - Falcon Protech3048 (TM) - Awl Protech3048 (TM) - Lightning StrykerPR3324 (GR, LS, VG) - PKG.40 DEG ANGLED CONVEX StrykerPR3324 (GR, LS, VG) - IRR JAGUAR CUTTER 3.5MM StrykerPR3324 (GR, LS, VG) - IRR JAGUAR CUTTER 4MM StrykerPR3324 (GR, LS, VG) - PKG.IRR.AGG.MENISCUS CUTTER Puritan5503 (NR) - Puritan, Polyester Tipped Applicators Aquabiliti1563 (SP,GR) - Saline-filled flush syringe Anodyne3068 (LN, LS) - PEYMAN BVI1689 (EP1) - Soft Tip Cannula BVI1689 (EP1) - LASIK Irrigating Cannula BVI1689 (EP1) - Flexible Tip Cannula BVI1689 (EP1) - Visitec Nucleus Hydrodissector BVI1689 (EP1) - Micro J Shape Cannula BVI1689 (EP1) - Irrigating Cystotome BVI1689 (EP1) - Anterior Chamber Cannula [Rycroft] BVI1689 (EP1) - Viscoflow Cannula BVI1689 (EP1) - Cortical Cleaving Hydrodissector BVI1689 (EP1) - Infusion Cannulas BVI1689 (EP1) - Lacrimal Cannula SonomedEscalon8890 (MN) - Viscous Fluid Cannula Nurse11268 (GR) - USP Sterile Water, 500mL, Screw Top Bottle Nurse11268 (GR) - USP Normal Saline, 500mL, Screw Top Bottle Nurse11268 (GR) - USP Normal Saline, 250mL Screw Top Bottle 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 BVI1689 (EP1) - Eye Bandage BVI1689 (EP1) - Guibor Eye Bubble Bandage Bayer1675 (GR) - [Spectris Solaris EP MR Injector System] Disposable MRI Kit for 65/115 MR Injector System Bayer1675 (GR) - Disposable MRI Kit for 65/115 MR Injector System Bayer1675 (GR) - Saline Syringe & Tubing for MR Injector System StrykerPR3324 (GR, LN, VG) - ACM; AEQUALIS PERFORM; AUTOPLEX; MIXER; MIXEVAC CEMENT MIXERS AND KITS; PCD; REVOLUTION Atricure2121 (GR, LN,* LS*) - AtriCure - AtriClip LAA Exclusion System Atricure2121 (GR, LN,* LS*) - AtriClip LAA Exclusion System Atricure2121 (GR, LN,* LS*) - Atricure - Gillinov-Cosgrove Selection Guide Haemonetics (GR) - NexSys PCS Enable Injections7153 (GR) - Empaveli Injections Atricure2121 (GR,LN*.LS*) - AtriClip FLEX-Mini LAA Exclusion System (ACHM)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2012-12-27
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-04-10
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2021-12-02
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2012-12-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-11-12
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2022-07-12
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-09-18
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2012-12-18
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2023-07-06
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2025-11-25
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-08-23
EXM	Truss, Umbilical	Gastroenterology, Urology	Class 1	876.5970	2019-12-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-11
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2019-12-31
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-08-23
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2022-08-23
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2012-12-18
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2023-07-27
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-03-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-04-21
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-10-31
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2012-11-14
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2024-09-18
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2012-12-27
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-08-23
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2022-08-23
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2022-08-23
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2013-01-08
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-01-08
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2012-12-27
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2013-01-07
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-07
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2019-10-30
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2019-10-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-06-02
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2013-01-28
PZX	Left Atrial Appendage Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-01-23
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2020-10-19
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2012-12-18
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2023-03-29
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2023-01-11
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2019-11-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-11
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2019-12-17
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2022-08-23
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2022-08-23
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-08-23
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-01-07
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-12-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-11
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-08-23
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2014-04-01
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2020-10-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-11
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2013-02-11
EFN	Cotton, Roll	Dental	Class 1	872.6050	2019-12-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-23
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2022-08-23
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-03-12
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-03-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-12-12
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2012-12-27
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2023-03-29
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2024-03-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-03-12
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2024-03-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-03-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-06-02
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2022-06-02
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-03-12
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2024-03-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-03-12
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2024-03-12
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-05-26
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2025-05-16
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-05-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-09-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-09-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-04-21
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-04-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-11
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-11-23
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2019-12-17
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2019-12-17
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2013-02-11
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2013-02-11
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2013-02-11
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2023-07-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-23
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-04-20
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2020-10-19
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	1994-04-11
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-08-23
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2022-05-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-11
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-12-17
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-12-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-01-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-05-22
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2025-05-22
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-05-22
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-05-22
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2025-05-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-05-22
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-12-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-12-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-11
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2013-01-30
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-11-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-11-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-11-19
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2023-07-27
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2022-08-23
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2022-08-23
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2022-08-23
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2012-11-16
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-09-18
PZX	Left Atrial Appendage Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-09-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-03-12
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2024-03-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-03-12
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2024-03-12
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2015-07-17
PZX	Left Atrial Appendage Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2023-01-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-05-02
QLF	On-Body Injector	General Hospital	Class 2	880.5860	2025-05-07
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-04-21
PZX	Left Atrial Appendage Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-09-18
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-09-18
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-09-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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STERIS Corporation

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Related 510(k) Records

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K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
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K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1526711. Last updated year: 2026. Please use registration number 1526711 when referencing this establishment in official correspondence.