Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1319660

FEI Number

1000136478

Entity Name

ISOMEDIX OPERATIONS INC.

City/State/Country

CHESTER, NY, US

Establishment Address

23 ELIZABETH DR., CHESTER, NY 10918, 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

CookVandergrift (CH1,WH*) - Blastomere Aspiration Pipette BVI1689 (CH1) - Ultracell PVA Eye Spears BVI1689 (CH1) - Ultracell® Cataract Kit BVI1689 (CH1) - Ultracell Eye Wick BVI1689 (CH1) - Ultracell Cellulose Eye Spears BVI1689 (CH1) - Ultracell Fluid Collection Bag With Wick BVI1689 (CH1) - Ultracell Instrument Wipes Lifenet2559 (CH1,WH*,LN*) - Arthrex SpeedFLEX Implant Lifenet2559 (CH1,WH*) - ReadiGraft BLX Putty CookVandergrift (CH1,WH*) - Embryo Biopsy Pipette 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 Pretium1202 (WT) - Leakbuster PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag with Procedure Pack (Ref 622281) PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag (Ref 622280) Merit1383 (SN) - Cultura Saliva Self Collection Kit PFMMedical6614 (TM) - ASEPT 2,000mL Drainage Bag (Ref M7058) PFMMedical (TM) - ASEPT 2,000mL Drainage Bag with Procedure Pack (Ref M7060) CorningME1979 (CH1) - Corning Closed Systems individually wrapped centrifuge tubes and accessories BD4590 (SP) - BD Vacutainer® No Additive (Z) Plus Tubes Kirwan2512 (CH1,NR) - Bipolar Disposable Cord Ensera7760 (SP) - ClarifEye Markers WolfX-Ray11781 (SP) - Steritatt 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 Premia (CH1) - ProMIS Fixation System NisshaMedical11704 (CH1,NR) - UltraFix NisshaMedical11704 (CH1,NR) - UltraFix MiniMite PDI2826 (CH1) - Hygea Sterile Saline Wipe Tyber6592 (WH,CH1) - Screw, Fixation, Bone Tyber6592 (WH,CH1) - Screw, Fixation, bone Kirwan2512 (CH1, NR) - Kirwan Monopolar Forceps Kirwan2512 (CH1,NR) - Kirwan Disposable Battery-powered Cautery, Model 41-61XX series DelcathSystems6324 (BP) - Delcath Dual Hemofiltration Cartridge Tyber6592 (WH,CH1) - Anatomical Plating System Premia (CH1) - ProMIS Extension Rod Kirwan2512 (CH1,NR) - Disposable Endoscopic Cord, Disposable Monopolar Cord Kirwan2512 (CH1,NR) - Monoplar Endoscopic Cord Paragon6351 (NR) - Weck EFX Shield Fascial Closure System Lifenet2559 (WH,CH1*) - I/C Graft Chamber 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 Premia (CH1) - TOPS System BioWave4291 (CH1,WH) - Percutaneous Electrodes 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 Tyber6592 (WH,CH1) - Tyber Medical ACIF; Tyber Medical ALIF; Tyber Medical DLIF; Tyber Medical OLIF; Tyber Medical PLIF; Tyber6592 (WH,CH1) - Tyber Medical TLIF 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 BVI1689 (EP1,CH1) - Collagen Temporary Implants 0.3mm x 2mm BVI1689 (EP1,CH1) - Collagen Temporary Implants 0.2mm x 2mm BVI1689 (EP1) - Collagen Implants Variety Pack BVI1689 (EP1) - Collagen Temporary Implants 0.4mm x 2mm Kirwan2512 (CH1,NR) - Needle Electrode, Microdissection Needles CorningME1979 (CH1) - Corning Disposable Spinner Flasks CorningAMG5859 (CH1) - Corning Disposable Spinner Flasks Kirwan2512 (CH1.NR) - Kirwan Disposable Nerve Stimulating Probes, 41-34XX Series Kirwan2512 (CH1.NR) - Monopolar Suction Stimulator Premia (CH1) - ProMIS Fixation System BVI1689 (CH1) - Ultracell Spears BVI1689 (CH1) - Ultraclean BVI1689 (CH1) - Ultracell Cellulose Eye Spears BVI1689 (CH1) - Visitec Fluid Control Lifenet2559 (WH,CH1*) - FlexiGRAFT GraftLink; FlexiGRAFT GraftLink TS Lifenet2559 (WH,CH1*) - FlexiGRAFT Sutured Lateral Ankle Tendon Construct Lifenet2559 (WH,CH1*) - FlexiGRAFT QuadLink Lifenet2559 (WH,CH1*) - FlexiGRAFT Connect; FlexiGRAFT Connect EXT Lifenet2559 (WH,CH1*) - Dual Link WhiteBurr3283 (WP, CH1) - Jazz Polisher Premia (CH1) - VersaLink Fixation System CookVandergrift (CH1,WH*) - Flexipet® Manipulation Pipette CookVandergrift (CH1,WH*) - Flexipet® Denuding Pipette Lifenet2559 (CH1,WH,LSRTC) - PliaFX Flo Kirwan2512 (CH1, NR) - Bipolar Suction Coagulator Kirwan2512 (CH1,NR) - Disposable Bipolar Coagulating Forceps Kirwan2512 (CH1,NR) - Disposable Bipolar Forceps Kirwan2512 (CH1,NR) - Disposable Bipolar Irrigating Forceps Medcomp5812 (WH,CH1) - Duralock Depuy (NR,CH1) - ATTUNE All Polyethylene Tibia Tyber6592 (WH,CH1) - Screw, Fixation, Bone Kirwan2512 (CH1.NR) - Wire Pass Drills, Cranio Blades ParkerLabs2952 (CH1, WH) - Aquasonic® 100 Sterile Ultrasound Transmission Gel Lifenet2559 (CH1, LN, WH*) - Arthrex AlloSync PushLock Suture Anchor Tyber6592 (WH,CH1) - Wedge System Depuy (NR,CH1) - SIGMA® High Performance Partial Knee System J&J2480 (CH1) - Band-Aid CorningME1979 (CH1) - Corning Spinner Flasks and accessories Tyber6592 (WH,CH1) - Anatomical Plating System Kirwan2512 (CH1.NR) - Disposable Irrigation Bipolar Cord Assembly Kirwan2512 (CH1.NR) - Disposable Bipolar Irrigating Cord Tyber6592 (WH,CH1) - Tyber Medical PT Interbody Spacer System Kirwan2512 (CH1,NR)- Disposable Bipolar Electrode Kirwan2512 (CH1,NR)- Disposable Bipolar Pencil Coagulator Kirwan2512 (CH1,NR) - Disposable Bipolar Probe BVI1689 (EP1, CH1) - Micro Flow Pre-Loaded Punctal Occluder Hologic (CH1,NR) - Securmark Biopsy Site Markers Tyber6592 (WH,CH1) - Tyber Medical PT Interbody Spacer System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2013-01-30
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2012-12-18
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2024-11-04
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-12-27
LEC	Grinder, Tissue	Pathology	Class 1	864.3010	2014-03-14
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2023-01-18
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-10-31
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-01-14
MQH	Microtools, Assisted Reproduction (Pipettes)	Obstetrics/Gynecology	Class 2	884.6130	2024-09-09
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2015-06-28
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2025-11-25
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2012-12-27
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-12-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2025-12-10
QGA	Penile Implant Surgical Accessories	Gastroenterology, Urology	Class 1	876.3500	2025-05-12
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2015-11-11
MBS	Filler, Bone Void, Non-Osteoinduction	Unknown	Class 3	N/A	2023-02-15
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	Class 2	884.6130	2022-08-02
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-11-07
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-12-05
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2012-11-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-09
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2013-03-26
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	1994-04-11
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-09-27
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2018-05-16
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-11-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-01-26
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-12-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-12-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-12-03
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-12-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-02-20
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-10-28
KYF	Implant, Eye Valve	Ophthalmic	Class 2	886.3920	2020-12-14
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2012-12-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-03-03
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2012-12-18
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-11-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-03-03
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-04-15
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2012-12-28
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2015-12-05
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2012-11-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-27
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-09
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	Class 2	886.4115	2012-11-09
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2017-08-02
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-12-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-12-05
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-12-05
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-12-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-12-28
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2012-11-16
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2018-01-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-01-04
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2018-01-04
FLD	Apparatus, Hemoperfusion, Sorbent	Gastroenterology, Urology	Class 2	876.5870	2018-01-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-12-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-09
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2018-02-22
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2017-08-02
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2021-10-18
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-12-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-12-28
OGO	Intraocular Pressure Lowering Implant	Unknown	Class 3	N/A	2024-10-17
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2013-01-30
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2020-01-29
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-12-27
QWK	Prosthesis, Posterior Spinal Elements	Unknown	Class 3	N/A	2024-12-03
NHI	Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief	Neurology	Class 2	882.5890	2012-11-07
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2012-11-07
KJA	Flask, Tissue Culture	Hematology	Class 1	864.2240	2012-12-28
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2012-11-26
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2012-11-26
HQR	Apparatus, Cautery, Radiofrequency, Ac-Powered	Ophthalmic	Class 2	886.4100	2012-11-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-06-12
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2020-12-18
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-12-27
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2013-01-08
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-01-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-10-27
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-10-27
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2019-09-27
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2012-11-16
KJF	System, Suspension, Cell Culture	Hematology	Class 1	864.2240	2013-12-18
LZU	Plug, Punctum	Unknown	Class U	N/A	2018-04-18
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2012-11-09
KJE	Spinner System, Cell Culture	Hematology	Class 1	864.2240	2013-12-18
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2017-08-02
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2012-11-09
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-12-03
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-12-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-12-03
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-01-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2020-01-23
NUN	Bone Grafting Material, Human Source	Dental	Class 2	872.3930	2013-10-28
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-12-16
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2015-06-28
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-12-20
EHL	Point, Abrasive	Dental	Class 1	872.6010	2023-01-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-12-03
MQH	Microtools, Assisted Reproduction (Pipettes)	Obstetrics/Gynecology	Class 2	884.6130	2024-09-09
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2026-04-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2026-04-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-09
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2012-12-18
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2013-01-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-10-27
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-10-28
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-06-25
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2012-11-16
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2012-11-16
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2025-11-25
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2012-11-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-02-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-17
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-09-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-09-08
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-09-08
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2025-09-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-27
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2022-10-27
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2012-11-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2012-10-18
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2012-11-16
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2012-12-18
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2012-11-19
OKO	Negative Pressure Wound Therapy Non-Powered Suction Apparatus	General, Plastic Surgery	Class 2	878.4683	2023-02-10
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2024-07-31
KJC	Bottle, Roller, Tissue Culture	Hematology	Class 1	864.2240	2013-12-18
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-12-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-12-10
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2012-12-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-27
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2022-10-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-27
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2012-11-19
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2022-07-08
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2022-07-08
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2024-07-31
OKO	Negative Pressure Wound Therapy Non-Powered Suction Apparatus	General, Plastic Surgery	Class 2	878.4683	2023-02-10
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-02-11
KJD	Spinner, Flask	Hematology	Class 1	864.2240	2023-03-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-27
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2015-12-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-09
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2012-11-15
LZU	Plug, Punctum	Unknown	Class U	N/A	2015-06-28
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-09-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-01-07
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2017-08-02
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2017-08-02
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-10-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-10-27
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2012-11-15

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
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3006306415	ORCA PRODUCTS LLC	Dothan, AL, US
3013517086	EQUIMEDICAL	Floriana, MT
3014653790	CHITOGEL LIMITED	Upper Hutt Wellington, NZ
3002789796	Legend Technical Services	Saint Paul, MN, US
3006113097	T-SCIENTIFIC INTERNATIONAL, INC.	SANTO DOMINGO Distrito Nacional, DO

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319660. Last updated year: 2026. Please use registration number 1319660 when referencing this establishment in official correspondence.