Isomedix Operations, Inc

Contract sterilizer · Ontario, CA

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

FDA registration: 2032098 (openFDA record; or search FDA's registration database)
FEI number: 3003058448
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: 1000 Sarah Pl, Ontario, CA 91761
Contract listings: 298 device listings, 174 product codes, first listed Apr 11, 1994
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
BRZ	Set, Blood Transfusion	Class II	General hospital	Contract sterilization	Sep 25, 2014
BSY	Catheters, Suction, Tracheobronchial	Class I	Anesthesiology	Contract sterilization	Oct 31, 2012
BTX	Board, Arm (With Cover), Sterile	Class I	General and plastic surgery	Contract sterilization	Jan 24, 2023
BXM	Stimulator, Nerve, Ac-Powered	Class II	Anesthesiology	Contract sterilization	Sep 18, 2024
BYI	Percussor, Powered-Electric	Class II	Anesthesiology	Contract sterilization	Oct 31, 2012
DQO	Catheter, Intravascular, Diagnostic	Class II	Cardiovascular	Contract sterilization	Mar 5, 2026
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Class II	Cardiovascular	Contract sterilization	Aug 26, 2021
DXC	Clamp, Vascular	Class II	Cardiovascular	Contract sterilization	Dec 18, 2012
DXT	Injector And Syringe, Angiographic	Class II	Cardiovascular	Contract sterilization	Jul 6, 2017
DZE	Implant, Endosseous, Root-Form	Class II	Dental	Contract sterilization	Nov 14, 2012
DZI	Drill, Bone, Powered	Class II	Dental	Contract sterilization	Nov 14, 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	May 4, 2023
ETN	Stimulator, Nerve	Class II	Ear, nose and throat	Contract sterilization	Feb 11, 2013
EZD	Catheter, Straight	Class II	Gastroenterology and urology	Contract sterilization	Jun 7, 2018
FCY	Bulb, Inflation, For Endoscope	Class I	Gastroenterology and urology	Contract sterilization	Jul 13, 2023
FDT	Duodenoscope And Accessories, Flexible/Rigid	Class II	Gastroenterology and urology	Contract sterilization	Oct 17, 2024
FEN	Device, Cystometric, Hydraulic	Class II	Gastroenterology and urology	Contract sterilization	Dec 27, 2012
FER	Anoscope And Accessories	Class II	Gastroenterology and urology	Contract sterilization	Dec 20, 2017
FGE	Stents, Drains And Dilators For The Biliary Ducts	Class II	Gastroenterology and urology	Contract sterilization	Jun 18, 2014
FIE	Needle, Fistula	Class II	Gastroenterology and urology	Contract sterilization	Mar 3, 2026
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Class II	Gastroenterology and urology	Contract sterilization	Nov 15, 2019
FMF	Syringe, Piston	Class II	General hospital	Contract sterilization	Dec 2, 2018
FMG	Stopcock, I.V. Set	Class II	General hospital	Contract sterilization	Dec 18, 2012
FMI	Needle, Hypodermic, Single Lumen	Class II	General hospital	Contract sterilization	Jan 23, 2020
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	Class II	General hospital	Contract sterilization	Jul 30, 2022
FPA	Set, Administration, Intravascular	Class II	General hospital	Contract sterilization	Nov 15, 2012
FPK	Tubing, Fluid Delivery	Class II	General hospital	Contract sterilization	Nov 15, 2012
FRN	Pump, Infusion	Class II	General hospital	Contract sterilization	Sep 16, 2024
FRO	Dressing, Wound, Drug	Unclassified	General and plastic surgery	Contract sterilization	Jan 26, 2022
FWZ	Operating Room Accessories Table Tray	Class I	General and plastic surgery	Contract sterilization	Aug 6, 2001
FXY	Hood, Surgical	Class II	General and plastic surgery	Contract sterilization	Nov 6, 2012
FYA	Gown, Surgical	Class II	General and plastic surgery	Contract sterilization	Nov 6, 2012
FZS	Curette, Surgical, General Use	Class I	General and plastic surgery	Contract sterilization	Jul 18, 2024
FZZ	Marker, Skin	Class I	General and plastic surgery	Contract sterilization	Apr 11, 1994
GAA	Needle, Aspiration And Injection, Disposable	Class I	General and plastic surgery	Contract sterilization	Nov 7, 2012
GAL	Suture, Absorbable, Natural	Class II	General and plastic surgery	Contract sterilization	Dec 18, 2012
GAP	Suture, Nonabsorbable, Silk	Class II	General and plastic surgery	Contract sterilization	Dec 26, 2022
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	Class II	General and plastic surgery	Contract sterilization	Dec 26, 2022
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 18, 2012
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	Class II	General and plastic surgery	Contract sterilization	Dec 26, 2022
GCJ	Laparoscope, General & Plastic Surgery	Class II	Gastroenterology and urology	Contract sterilization	Jun 20, 2014
GDW	Staple, Implantable	Class II	General and plastic surgery	Contract sterilization	Mar 5, 2026
GDX	Scalpel, One-Piece	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
GDY	Gauze/Sponge, Internal, X-Ray Detectable	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
GEE	Brush, Biopsy, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Dec 3, 2025
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	May 25, 2018
GES	Blade, Scalpel	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
GEY	Motor, Surgical Instrument, Ac-Powered	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
GKT	Separator, Automated, Blood Cell, Diagnostic	Class II	Hematology	Contract sterilization	Dec 4, 2024
GWF	Stimulator, Electrical, Evoked Response	Class II	Neurology	Contract sterilization	Feb 11, 2013
GXL	Screwdriver, Skullplate	Class I	Neurology	Contract sterilization	Nov 11, 2022
GZT	Retractor, Self-Retaining, For Neurosurgery	Class II	Neurology	Contract sterilization	Jan 7, 2013
HCY	Curette, Uterine	Class I	Obstetrics and gynecology	Contract sterilization	Nov 8, 2012
HDB	Extractor, Vacuum, Fetal	Class II	Obstetrics and gynecology	Contract sterilization	Dec 20, 2012
HEW	Culdoscope (And Accessories)	Class II	Obstetrics and gynecology	Contract sterilization	Sep 25, 2019
HFB	Forceps, Biopsy, Gynecological	Class I	Obstetrics and gynecology	Contract sterilization	Apr 10, 2023
HFN	Transducer, Pressure, Intrauterine	Class II	Obstetrics and gynecology	Contract sterilization	Dec 20, 2012
HGP	Electrode, Circular (Spiral), Scalp And Applicator	Class II	Obstetrics and gynecology	Contract sterilization	Dec 20, 2012
HMX	Cannula, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Dec 27, 2012
HNF	Scissors, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Dec 28, 2012
HNI	Retractor, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Dec 27, 2012
HNN	Knife, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Dec 27, 2012
HNR	Forceps, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Dec 28, 2012
HOC	Clip, Iris Retractor	Class I	Ophthalmic	Contract sterilization	Dec 28, 2012
HOZ	Sponge, Ophthalmic	Class II	Ophthalmic	Contract sterilization	Jul 18, 2014
HQC	Unit, Phacofragmentation	Class II	Ophthalmic	Contract sterilization	Dec 19, 2012
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Dec 20, 2012
HRX	Arthroscope	Class II	Orthopedic	Contract sterilization	May 18, 2020
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract sterilization	Dec 20, 2012
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract sterilization	Dec 20, 2012
HTJ	Gauge, Depth	Class I	Orthopedic	Contract sterilization	Oct 23, 2020
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract sterilization	Dec 13, 2017
HTW	Bit, Drill	Class I	Orthopedic	Contract sterilization	Dec 27, 2012
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract sterilization	Dec 20, 2012
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Dec 20, 2012
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
HWK	Trephine	Class I	Orthopedic	Contract sterilization	Jan 7, 2013
HWQ	Passer	Class I	Orthopedic	Contract sterilization	Jan 7, 2013
HXG	Tamp	Class I	Orthopedic	Contract sterilization	May 18, 2020
HXI	Passer, Wire, Orthopedic	Class I	Orthopedic	Contract sterilization	Mar 13, 2017
IKN	Electromyograph, Diagnostic	Class II	Physical medicine	Contract sterilization	Feb 11, 2013
JDQ	Cerclage, Fixation	Class II	Orthopedic	Contract sterilization	Dec 20, 2012
JDR	Staple, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Nov 22, 2016
JEC	Component, Traction, Invasive	Class II	Orthopedic	Contract sterilization	Dec 20, 2012
JEY	Plate, Bone	Class II	Dental	Contract sterilization	Nov 14, 2012
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Class I	Clinical chemistry	Contract sterilization	Sep 11, 2024
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Class II	Clinical chemistry	Contract sterilization	Jun 23, 2023
JOL	Catheter And Tip, Suction	Class II	General hospital	Contract sterilization	Dec 27, 2012
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Class I	Clinical chemistry	Contract sterilization	Nov 17, 2019
KCJ	Applicator, Ent	Class I	Ear, nose and throat	Contract sterilization	Apr 1, 2014
KCO	Nasal Spray, Ent Delivery	Class I	Ear, nose and throat	Contract sterilization	Dec 2, 2021
KCY	Tourniquet, Pneumatic	Class I	General and plastic surgery	Contract sterilization	May 19, 2016
KDD	Kit, Surgical Instrument, Disposable	Class I	General and plastic surgery	Contract sterilization	Dec 28, 2012
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Class II	Gastroenterology and urology	Contract sterilization	Jan 29, 2013
KGX	Tape And Bandage, Adhesive	Class I	General hospital	Contract sterilization	Nov 16, 2012
KGZ	Accessories, Catheter	Class I	General and plastic surgery	Contract sterilization	Dec 2, 2018
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract sterilization	Dec 20, 2012
KJF	System, Suspension, Cell Culture	Class I	Hematology	Contract sterilization	Dec 18, 2013
KNT	Tubes, Gastrointestinal (And Accessories)	Class II	Gastroenterology and urology	Contract sterilization	Oct 31, 2012
KNW	Instrument, Biopsy	Class II	Gastroenterology and urology	Contract sterilization	Nov 21, 2019
KNY	Accessories, Catheter, G-U	Class II	Gastroenterology and urology	Contract sterilization	May 20, 2024
KOD	Catheter, Urological	Class II	Gastroenterology and urology	Contract sterilization	Apr 8, 2014
KPE	Container, I.V.	Class II	General hospital	Contract sterilization	Feb 3, 2022
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class II	Orthopedic	Contract sterilization	Dec 20, 2012
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract sterilization	Mar 24, 2014
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract sterilization	Mar 24, 2014
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	Orthopedic	Contract sterilization	Jun 23, 2023
KYG	Device, Irrigation, Ocular Surgery	Class I	Ophthalmic	Contract sterilization	Dec 27, 2012
KYX	Dispenser, Liquid Medication	Class I	General hospital	Contract sterilization	Apr 10, 2023
LGZ	Warmer, Thermal, Infusion Fluid	Class II	General hospital	Contract sterilization	Jan 29, 2013
LHI	Set, I.V. Fluid Transfer	Class II	General hospital	Contract sterilization	Feb 11, 2013
LKF	Cannula, Manipulator/Injector, Uterine	Class II	Obstetrics and gynecology	Contract sterilization	Dec 20, 2012
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unclassified	Gastroenterology and urology	Contract sterilization	Jul 17, 2015
LPB	Cardiac Ablation Percutaneous Catheter	Class III	Cardiovascular	Contract sterilization	Aug 26, 2021
LPZ	Container, Frozen Donor Tissue Storage	Unclassified	General hospital	Contract sterilization	Nov 11, 2019
LRN	Wire, Surgical	Class II	Orthopedic	Contract sterilization	Dec 20, 2012
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Class I	Clinical chemistry	Contract sterilization	Nov 8, 2012
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	Dec 13, 2017
LYA	Splint, Intranasal Septal	Class I	Ear, nose and throat	Contract sterilization	Jan 30, 2013
LYC	Bone Grafting Material, Synthetic	Class II	Dental	Contract sterilization	Nov 14, 2012
LYV	Label Or Tag, Sterile	Class I	General and plastic surgery	Contract sterilization	Nov 7, 2012
LZU	Plug, Punctum	Unclassified	Ophthalmic	Contract sterilization	Jan 30, 2013
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract sterilization	Mar 24, 2014
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Dec 13, 2017
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract sterilization	Dec 28, 2012
MHW	Dressing, Compression	Class I	General hospital	Contract sterilization	Sep 10, 2020
MJC	Catheter, Urological (Antimicrobial) And Accessories	Class II	Gastroenterology and urology	Contract sterilization	Jun 7, 2018
MJO	Prosthesis, Intervertebral Disc	Class III	Orthopedic	Contract sterilization	Feb 11, 2013
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract sterilization	Mar 24, 2014
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract sterilization	Mar 24, 2014
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract sterilization	Mar 24, 2014
MQV	Filler, Bone Void, Calcium Compound	Class II	Orthopedic	Contract sterilization	Dec 18, 2012
MTJ	Wax, Bone	Unclassified	Orthopedic	Contract sterilization	Dec 18, 2012
NAY	System, Surgical, Computer Controlled Instrument	Class II	Gastroenterology and urology	Contract sterilization	Mar 5, 2026
NDN	Cement, Bone, Vertebroplasty	Class II	Orthopedic	Contract sterilization	May 18, 2020
NHA	Abutment, Implant, Dental, Endosseous	Class II	Dental	Contract sterilization	Nov 14, 2012
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Class II	Ear, nose and throat	Contract sterilization	Jan 30, 2013
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract sterilization	Mar 24, 2014
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract sterilization	Dec 4, 2019
NNI	Container, Specimen, Non-Sterile	Class I	Pathology	Contract sterilization	Dec 3, 2025
NQM	Immunoassay For Detection Of Amniotic Fluid Protein(S).	Class I	Clinical chemistry	Contract sterilization	Sep 11, 2024
NZK	Stimulator, Low Electric Field, Tumor Treatment	Class III	Neurology	Contract sterilization	Feb 16, 2023
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Class III	Cardiovascular	Contract sterilization	Aug 26, 2021
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Class III	Cardiovascular	Contract sterilization	Aug 26, 2021
OAO	Cord Blood Processing System And Storage Container	Class II	Hematology	Contract sterilization	Nov 19, 2020
OAT	Implant, Endosseous, Orthodontic	Class II	Dental	Contract sterilization	Oct 9, 2020
ODC	Endoscope Channel Accessory	Class II	Gastroenterology and urology	Contract sterilization	Jun 17, 2014
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract sterilization	Nov 27, 2013
OGQ	Ear Irrigation Kit	Class I	General hospital	Contract sterilization	Jan 28, 2013
OJK	Eye Tray	Class II	Ophthalmic	Contract sterilization	Jan 28, 2013
OLR	Oral Wound Dressing	Unclassified	Dental	Contract sterilization	Dec 19, 2012
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	Class II	General hospital	Contract sterilization	Dec 2, 2018
OUR	Sacroiliac Joint Fixation	Class II	Orthopedic	Contract sterilization	Dec 13, 2017
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract sterilization	Mar 24, 2014
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract sterilization	Dec 5, 2018
PEK	Spinous Process Plate	Class II	Orthopedic	Contract sterilization	May 9, 2024
PHQ	Anterior Staple As Supplemental Fixation For Fusion	Class II	Orthopedic	Contract sterilization	Jun 23, 2023
PYB	Minor Surgical Procedures Tray	Class I	General and plastic surgery	Contract sterilization	Mar 12, 2020
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Class II	Clinical chemistry	Contract sterilization	Feb 12, 2024
QBP	Cap, Device Disinfectant	Class II	General hospital	Contract sterilization	Jan 4, 2017
QCZ	Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator	Class III	Hematology	Contract sterilization	Nov 1, 2019
QDK	Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management	Class II	Clinical chemistry	Contract sterilization	Feb 12, 2024
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Class II	Cardiovascular	Contract sterilization	Mar 5, 2026
QFG	Alternate Controller Enabled Insulin Infusion Pump	Class II	Clinical chemistry	Contract sterilization	Jan 20, 2023
QGZ	Electrical Tumor Treatment Fields	Class III	Anesthesiology	Contract sterilization	Apr 10, 2023
QII	Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use	Class II	Clinical chemistry	Contract sterilization	Feb 12, 2024
QPB	System, Suction, Lipoplasty For Removal	Class II	General and plastic surgery	Contract sterilization	Nov 21, 2025
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unclassified	General and plastic surgery	Contract sterilization	Dec 19, 2012
QWY	Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator	Class III	Hematology	Contract sterilization	Oct 13, 2023
SBF	Orthopedic Augmented Reality	Class II	Neurology	Contract sterilization	Dec 2, 2025
SDA	Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer	Class III	Anesthesiology	Contract sterilization	Aug 28, 2025

Isomedix Operations, Inc

Devices listed as contract work

Other contract facilities of STERIS Corporation