ISOMEDIX OPERATIONS INC.

Contract sterilizer · Whippany, NJ

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

1992Product codes first listed, by year (tallest: 47)2026

FDA registration: 2245304 (openFDA record; or search FDA's registration database)
FEI number: 2245304
Registered for: FDA registration year 2026
Establishment types: Manufacturer for export only; Contract sterilizer
Owner or operator: STERIS Corporation (FDA owner/operator no. 1527821)
Registered address: 9 Apollo Dr, Whippany, NJ 07981
Contract listings: 357 device listings, 142 product codes, first listed Dec 2, 1992
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
DWS	Instruments, Surgical, Cardiovascular	Class I	Cardiovascular	Contract sterilization	Dec 27, 2012
DXC	Clamp, Vascular	Class II	Cardiovascular	Contract sterilization	Dec 17, 2012
DZE	Implant, Endosseous, Root-Form	Class II	Dental	Contract sterilization	Nov 8, 2012
DZP	Instrument, Diamond, Dental	Class I	Dental	Contract sterilization	Jan 18, 2023
EFQ	Gauze/Sponge, Internal	Unclassified	General and plastic surgery	Contract sterilization	Mar 24, 2014
EHL	Point, Abrasive	Class I	Dental	Contract sterilization	Jan 18, 2023
EJL	Bur, Dental	Class I	Dental	Contract sterilization	Dec 28, 2012
EKS	File, Pulp Canal, Endodontic	Class I	Dental	Contract sterilization	Oct 7, 2020
EMF	Knife, Surgical	Class I	General and plastic surgery	Contract sterilization	Dec 28, 2012
EMX	Balloon, Epistaxis	Class I	Ear, nose and throat	Contract sterilization	Dec 27, 2012
EYK	Connector, Ureteral Catheter	Class I	Gastroenterology and urology	Contract sterilization	Nov 30, 2015
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Class II	Gastroenterology and urology	Contract sterilization	Dec 18, 2012
FMF	Syringe, Piston	Class II	General hospital	Contract sterilization	Dec 3, 2019
FQH	Lavage, Jet	Class II	General hospital	Contract sterilization	Jan 8, 2013
FRO	Dressing, Wound, Drug	Unclassified	General and plastic surgery	Contract sterilization	Jan 8, 2013
FTM	Mesh, Surgical	Class II	General and plastic surgery	Contract sterilization	Nov 16, 2012
FTY	Tape, Measuring, Rulers And Calipers	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
FZS	Curette, Surgical, General Use	Class I	General and plastic surgery	Contract sterilization	Apr 8, 2014
FZT	Cutter, Surgical	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
FZZ	Marker, Skin	Class I	General and plastic surgery	Contract sterilization	Apr 11, 1994
GAD	Retractor	Class I	General and plastic surgery	Contract sterilization	Sep 11, 2013
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	Class II	General and plastic surgery	Contract sterilization	Dec 18, 2012
GAO	Suture, Nonabsorbable	Class II	General and plastic surgery	Contract sterilization	Feb 18, 2026
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	Class II	General and plastic surgery	Contract sterilization	Dec 18, 2012
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	Class II	General and plastic surgery	Contract sterilization	Dec 20, 2012
GAX	Tourniquet, Nonpneumatic	Class I	General and plastic surgery	Contract sterilization	Nov 7, 2012
GBX	Catheter, Irrigation	Class I	General and plastic surgery	Contract sterilization	Dec 18, 2012
GCJ	Laparoscope, General & Plastic Surgery	Class II	Gastroenterology and urology	Contract sterilization	Nov 19, 2012
GDY	Gauze/Sponge, Internal, X-Ray Detectable	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
GEA	Cannula, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	Dec 17, 2012
GES	Blade, Scalpel	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
GEX	Powered Laser Surgical Instrument	Class II	General and plastic surgery	Contract sterilization	Apr 8, 2014
GEY	Motor, Surgical Instrument, Ac-Powered	Class I	General and plastic surgery	Contract sterilization	Jan 30, 2013
GFF	Bur, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
GFG	Bit, Surgical	Class I	General and plastic surgery	Contract sterilization	Sep 1, 2022
GXP	Methyl Methacrylate For Cranioplasty	Class II	Neurology	Contract sterilization	Jan 23, 2020
GXQ	Dura Substitute	Class II	Neurology	Contract sterilization	Nov 16, 2012
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Class II	Neurology	Contract sterilization	Nov 7, 2012
GZX	Instrument, Microsurgical	Class I	Neurology	Contract sterilization	Nov 8, 2022
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract sterilization	Dec 1, 2025
HCF	Instrument, Ligature Passing And Knot Tying	Class I	General and plastic surgery	Contract sterilization	Feb 22, 2018
HEE	Set, Anesthesia, Paracervical	Class II	Obstetrics and gynecology	Contract sterilization	Nov 8, 2012
HIH	Hysteroscope (And Accessories)	Class II	Obstetrics and gynecology	Contract sterilization	Dec 4, 2024
HKY	Tonometer, Manual	Class II	Ophthalmic	Contract sterilization	Dec 14, 2017
HNN	Knife, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Dec 27, 2012
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Oct 27, 2022
HRX	Arthroscope	Class II	Orthopedic	Contract sterilization	Mar 3, 2014
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract sterilization	Nov 8, 2012
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Nov 8, 2012
HTO	Reamer	Class I	Orthopedic	Contract sterilization	Jan 7, 2013
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract sterilization	Jan 26, 2024
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Class II	Radiology	Contract sterilization	Dec 1, 2025
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Class II	Radiology	Contract sterilization	Oct 18, 2012
JAC	System, X-Ray, Film Marking, Radiographic	Class I	Radiology	Contract sterilization	Apr 2, 2025
JDC	Prosthesis, Elbow, Constrained, Cemented	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	Class II	Orthopedic	Contract sterilization	Apr 18, 2018
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
JDJ	Mesh, Surgical, Acetabular, Hip, Prosthesis	Class II	General and plastic surgery	Contract sterilization	Feb 11, 2013
JDK	Prosthesis, Hip, Cement Restrictor	Class II	General and plastic surgery	Contract sterilization	Feb 11, 2013
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Class III	Orthopedic	Contract sterilization	Feb 11, 2013
JDR	Staple, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Aug 30, 2023
JDW	Pin, Fixation, Threaded	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
JWJ	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	Class II	Orthopedic	Contract sterilization	Jan 5, 2023
JXI	Cuff, Nerve	Class II	Neurology	Contract sterilization	Nov 16, 2012
KCN	Ear Wick	Class I	Ear, nose and throat	Contract sterilization	Dec 27, 2012
KDD	Kit, Surgical Instrument, Disposable	Class I	General and plastic surgery	Contract sterilization	Dec 28, 2012
KDP	Regulator, Vacuum	Class II	General hospital	Contract sterilization	Nov 15, 2019
KGN	Wound Dressing With Animal-Derived Material(S)	Unclassified	General and plastic surgery	Contract sterilization	Nov 19, 2012
KGW	Ring (Wound Protector), Drape Retention, Internal	Class II	General and plastic surgery	Contract sterilization	May 26, 2023
KRD	Device, Vascular, For Promoting Embolization	Class II	Cardiovascular	Contract sterilization	Jun 28, 2023
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Nov 8, 2012
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Class III	Orthopedic	Contract sterilization	Mar 1, 2018
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Class II	Orthopedic	Contract sterilization	Nov 8, 2012
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract sterilization	Nov 30, 2020
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
KXA	Prosthesis, Hip, Femoral, Resurfacing	Class II	Orthopedic	Contract sterilization	Nov 8, 2012
LHI	Set, I.V. Fluid Transfer	Class II	General hospital	Contract sterilization	Oct 18, 2021
LJW	Tracheotome	Class I	Ear, nose and throat	Contract sterilization	Apr 18, 2018
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
LRW	Scissors, General, Surgical	Class I	General and plastic surgery	Contract sterilization	Jun 29, 2023
LWE	Bone Marrow Collection/Transfusion Kit	Class II	General hospital	Contract sterilization	Jan 7, 2013
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract sterilization	Oct 31, 2012
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Class II	Orthopedic	Contract sterilization	Jan 26, 2024
LYC	Bone Grafting Material, Synthetic	Class II	Dental	Contract sterilization	Nov 8, 2012
LZN	Cement Obturator	Class II	General and plastic surgery	Contract sterilization	Feb 11, 2013
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
LZU	Plug, Punctum	Unclassified	Ophthalmic	Contract sterilization	Jan 30, 2013
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Dec 10, 2025
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract sterilization	Nov 30, 2020
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Class II	Orthopedic	Contract sterilization	Mar 1, 2018
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Dec 10, 2025
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class II	Orthopedic	Contract sterilization	Mar 2, 2018
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Class II	Orthopedic	Contract sterilization	Dec 19, 2012
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract sterilization	Dec 28, 2012
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
MJT	Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented	Class III	Orthopedic	Contract sterilization	Feb 11, 2013
MQH	Microtools, Assisted Reproduction (Pipettes)	Class II	Obstetrics and gynecology	Contract sterilization	Nov 27, 2012
MQK	Labware, Assisted Reproduction	Class II	Obstetrics and gynecology	Contract sterilization	Jun 19, 2023
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract sterilization	Jan 22, 2018
MQV	Filler, Bone Void, Calcium Compound	Class II	Orthopedic	Contract sterilization	Nov 16, 2012
MTJ	Wax, Bone	Unclassified	Orthopedic	Contract sterilization	Oct 26, 2022
MWS	Stabilizer, Heart	Class I	Cardiovascular	Contract sterilization	Dec 27, 2012
MZM	Fibrin Sealant Preparation Device	Class II	General hospital	Contract sterilization	Oct 9, 2019
NAB	Gauze / Sponge,Nonresorbable For External Use	Class I	General and plastic surgery	Contract sterilization	Dec 2, 1992
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract sterilization	Dec 27, 2012
NHI	Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief	Class II	Neurology	Contract sterilization	Nov 7, 2012
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	Class III	Orthopedic	Contract sterilization	Jan 17, 2013
NOX	Filler, Bone Void, Synthetic Peptide	Class III	Orthopedic	Contract sterilization	Jan 17, 2022
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Feb 11, 2013
NPL	Barrier, Animal Source, Intraoral	Class II	Dental	Contract sterilization	Nov 16, 2012
NPM	Bone Grafting Material, Animal Source	Class II	Dental	Contract sterilization	Nov 16, 2012
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Class II	Radiology	Contract sterilization	Feb 9, 2024
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Class I	Orthopedic	Contract sterilization	Dec 27, 2012
OCW	Endoscopic Tissue Approximation Device	Class II	Gastroenterology and urology	Contract sterilization	Jan 7, 2013
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract sterilization	Nov 30, 2020
OGZ	Catheter, Intravascular, Plaque Morphology Evaluation	Class II	Cardiovascular	Contract sterilization	Feb 9, 2024
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Class II	Orthopedic	Contract sterilization	Nov 30, 2018
OLC	Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen	Class II	General and plastic surgery	Contract sterilization	Sep 18, 2025
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract sterilization	Sep 21, 2026
OOG	Knee Arthroplasty Implantation System	Class II	Orthopedic	Contract sterilization	Mar 2, 2018
ORD	Optical Coherence Tomography, Intravascular Catheter	Class II	Cardiovascular	Contract sterilization	Feb 9, 2024
ORG	Platelet And Plasma Separator For Bone Graft Handling	Class II	Hematology	Contract sterilization	Dec 3, 2020
OVB	Hydrogel Spacer	Class II	Radiology	Contract sterilization	Jul 20, 2023
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	Class II	General and plastic surgery	Contract sterilization	Dec 10, 2025
PDK	Cream For X-Ray Attenuation	Class II	Radiology	Contract sterilization	Feb 9, 2018
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract sterilization	Dec 4, 2014
PLF	Bone Wedge	Class II	Orthopedic	Contract sterilization	Oct 27, 2022
PMQ	Peripheral Blood Processing Device For Wound Management	Class II	Hematology	Contract sterilization	Jul 11, 2023
POD	Temporary, Internal Use Hemostatic	Class II	General and plastic surgery	Contract sterilization	Jan 8, 2024
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Class II	Obstetrics and gynecology	Contract sterilization	Aug 2, 2022
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unclassified	General and plastic surgery	Contract sterilization	Jan 30, 2013
QSZ	Absorbable Synthetic Wound Dressing	Unclassified	General and plastic surgery	Contract sterilization	Feb 9, 2018

ISOMEDIX OPERATIONS INC.

Devices listed as contract work

Other contract facilities of STERIS Corporation