Isomedix Operations Inc.

Contract sterilizer · San Diego, CA

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

FDA registration: 2032112 (openFDA record; or search FDA's registration database)
FEI number: 3003076831
Registered for: FDA registration year 2026
Establishment types: Manufacturer for export only; Contract sterilizer
Owner or operator: STERIS Corporation (FDA owner/operator no. 9072619)
Registered address: 7685 ST.ANDREWS AVE., San Diego, CA 92154
Contract listings: 242 device listings, 131 product codes, first listed Oct 19, 2012
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
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Class II	Anesthesiology	Contract sterilization	Nov 13, 2020
BSY	Catheters, Suction, Tracheobronchial	Class I	Anesthesiology	Contract sterilization	Nov 6, 2012
BTO	Tube, Tracheostomy (W/Wo Connector)	Class II	Anesthesiology	Contract sterilization	Nov 6, 2012
BTR	Tube, Tracheal (W/Wo Connector)	Class II	Anesthesiology	Contract sterilization	Jan 8, 2013
BZA	Connector, Airway (Extension)	Class I	Anesthesiology	Contract sterilization	Jan 8, 2013
BZQ	Monitor, Breathing Frequency	Class II	Anesthesiology	Contract sterilization	Dec 17, 2012
BZT	Stethoscope, Esophageal, With Electrical Conductors	Class II	Anesthesiology	Contract sterilization	Jan 8, 2013
BZW	Stethoscope, Esophageal	Class I	Anesthesiology	Contract sterilization	Jan 8, 2013
CAC	Apparatus, Autotransfusion	Class II	Anesthesiology	Contract sterilization	Dec 12, 2013
CAF	Nebulizer (Direct Patient Interface)	Class II	Anesthesiology	Contract sterilization	Nov 30, 2015
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Class II	Anesthesiology	Contract sterilization	Jan 8, 2013
CJY	Azo Dye, Calcium	Class II	Clinical chemistry	Contract sterilization	Jul 11, 2023
DPZ	Oximeter, Ear	Class II	Cardiovascular	Contract sterilization	Dec 17, 2012
DQA	Oximeter	Class II	Cardiovascular	Contract sterilization	Dec 17, 2012
DQK	Computer, Diagnostic, Programmable	Class II	Cardiovascular	Contract sterilization	Jan 5, 2021
DQO	Catheter, Intravascular, Diagnostic	Class II	Cardiovascular	Contract sterilization	Dec 17, 2012
DQY	Catheter, Percutaneous	Class II	Cardiovascular	Contract sterilization	Dec 28, 2012
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Class II	Cardiovascular	Contract sterilization	Jan 5, 2021
DRS	Transducer, Blood-Pressure, Extravascular	Class II	Cardiovascular	Contract sterilization	Dec 17, 2012
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Class II	Cardiovascular	Contract sterilization	Dec 17, 2012
DTW	Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass	Class II	Cardiovascular	Contract sterilization	Jan 8, 2013
DWJ	System, Thermal Regulating	Class II	Cardiovascular	Contract sterilization	Nov 27, 2015
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Class II	Cardiovascular	Contract sterilization	Dec 17, 2012
DXT	Injector And Syringe, Angiographic	Class II	Cardiovascular	Contract sterilization	Dec 14, 2023
DYB	Introducer, Catheter	Class II	Cardiovascular	Contract sterilization	Apr 26, 2013
EBI	Resin, Denture, Relining, Repairing, Rebasing	Class II	Dental	Contract sterilization	Jul 12, 2023
EFA	Handpiece, Belt And/Or Gear Driven, Dental	Class I	Dental	Contract sterilization	Jul 12, 2023
EOQ	Bronchoscope (Flexible Or Rigid)	Class II	Ear, nose and throat	Contract sterilization	Jun 22, 2023
EXR	Urinometer, Mechanical	Class II	Gastroenterology and urology	Contract sterilization	May 31, 2023
EZD	Catheter, Straight	Class II	Gastroenterology and urology	Contract sterilization	Nov 6, 2012
EZL	Catheter, Retention Type, Balloon	Class II	Gastroenterology and urology	Contract sterilization	Oct 19, 2012
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Class II	Gastroenterology and urology	Contract sterilization	May 30, 2023
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Class II	Gastroenterology and urology	Contract sterilization	May 30, 2023
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Class II	Gastroenterology and urology	Contract sterilization	Nov 6, 2012
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Class II	Gastroenterology and urology	Contract sterilization	May 30, 2023
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Class II	Gastroenterology and urology	Contract sterilization	Jan 29, 2013
FLL	Continuous Measurement Thermometer	Class II	General hospital	Contract sterilization	Jan 8, 2013
FMF	Syringe, Piston	Class II	General hospital	Contract sterilization	Dec 2, 2018
FMG	Stopcock, I.V. Set	Class II	General hospital	Contract sterilization	Dec 17, 2012
FMI	Needle, Hypodermic, Single Lumen	Class II	General hospital	Contract sterilization	Jan 8, 2013
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	Class II	General hospital	Contract sterilization	Dec 2, 2018
FPA	Set, Administration, Intravascular	Class II	General hospital	Contract sterilization	Nov 5, 2012
FPK	Tubing, Fluid Delivery	Class II	General hospital	Contract sterilization	May 31, 2023
FRN	Pump, Infusion	Class II	General hospital	Contract sterilization	Jan 8, 2013
FTL	Mesh, Surgical, Polymeric	Class II	General and plastic surgery	Contract sterilization	Jul 10, 2023
FYD	Apparatus, Exhaust, Surgical	Class II	General and plastic surgery	Contract sterilization	Dec 30, 2019
GAG	Stapler, Surgical	Class II	General hospital	Contract sterilization	Sep 25, 2024
GAZ	Tubing, Noninvasive	Class II	General hospital	Contract sterilization	Dec 20, 2012
GBM	Catheter, Urethral	Class II	Gastroenterology and urology	Contract sterilization	Nov 6, 2012
GCJ	Laparoscope, General & Plastic Surgery	Class II	Gastroenterology and urology	Contract sterilization	Nov 11, 2020
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	Class II	General hospital	Contract sterilization	Nov 5, 2012
GDW	Staple, Implantable	Class II	General and plastic surgery	Contract sterilization	Mar 24, 2023
GDY	Gauze/Sponge, Internal, X-Ray Detectable	Class I	General and plastic surgery	Contract sterilization	Dec 20, 2012
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	Nov 11, 2020
GEX	Powered Laser Surgical Instrument	Class II	General and plastic surgery	Contract sterilization	Nov 11, 2020
GGM	Control, Hemoglobin	Class II	Hematology	Contract sterilization	Jul 10, 2023
GKT	Separator, Automated, Blood Cell, Diagnostic	Class II	Hematology	Contract sterilization	Dec 12, 2013
GKZ	Counter, Differential Cell	Class II	Hematology	Contract sterilization	Jul 11, 2023
GWM	Device, Monitoring, Intracranial Pressure	Class II	Neurology	Contract sterilization	Jun 19, 2023
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Class II	Neurology	Contract sterilization	Jul 10, 2023
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract sterilization	Jul 10, 2023
HCA	Catheter, Ventricular	Class II	Neurology	Contract sterilization	Jun 19, 2023
HGI	Electrocautery, Gynecologic (And Accessories)	Class II	Obstetrics and gynecology	Contract sterilization	Mar 24, 2023
IKD	Cable, Electrode	Class II	Physical medicine	Contract sterilization	May 31, 2023
JAK	System, X-Ray, Tomography, Computed	Class II	Radiology	Contract sterilization	Jul 10, 2023
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Class II	Radiology	Contract sterilization	Jul 12, 2023
JAY	Support, Breathing Tube	Class I	Anesthesiology	Contract sterilization	Jan 8, 2013
JEC	Component, Traction, Invasive	Class II	Orthopedic	Contract sterilization	Apr 26, 2013
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Class II	Clinical chemistry	Contract sterilization	Jan 8, 2013
JOH	Tube Tracheostomy And Tube Cuff	Class II	Anesthesiology	Contract sterilization	Sep 9, 2019
JOL	Catheter And Tip, Suction	Class II	General hospital	Contract sterilization	May 31, 2023
JTN	Susceptibility Test Discs, Antimicrobial	Class II	Microbiology	Contract sterilization	Jul 11, 2023
JXG	Shunt, Central Nervous System And Components	Class II	Neurology	Contract sterilization	Jun 19, 2023
KGO	Surgeon'S Gloves	Class I	General and plastic surgery	Contract sterilization	Jul 10, 2023
KGZ	Accessories, Catheter	Class I	General and plastic surgery	Contract sterilization	Dec 2, 2018
KKX	Drape, Surgical, Antimicrobial	Class II	General and plastic surgery	Contract sterilization	Jul 10, 2023
KNT	Tubes, Gastrointestinal (And Accessories)	Class II	Gastroenterology and urology	Contract sterilization	Nov 5, 2012
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Class II	Gastroenterology and urology	Contract sterilization	May 30, 2023
KNY	Accessories, Catheter, G-U	Class II	Gastroenterology and urology	Contract sterilization	Nov 6, 2012
KOC	Accessories, Blood Circuit, Hemodialysis	Class II	Gastroenterology and urology	Contract sterilization	Jan 29, 2013
KOD	Catheter, Urological	Class II	Gastroenterology and urology	Contract sterilization	Nov 6, 2012
KRA	Catheter, Continuous Flush	Class II	Cardiovascular	Contract sterilization	Dec 17, 2012
KRB	Probe, Thermodilution	Class II	Cardiovascular	Contract sterilization	Dec 17, 2012
KRD	Device, Vascular, For Promoting Embolization	Class II	Cardiovascular	Contract sterilization	Jul 10, 2023
KSW	System, Processing For Frozen Blood	Class II	Hematology	Contract sterilization	Dec 12, 2013
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract sterilization	Apr 26, 2013
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Class II	Orthopedic	Contract sterilization	Apr 26, 2013
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract sterilization	Jul 12, 2023
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract sterilization	Jul 12, 2023
KYX	Dispenser, Liquid Medication	Class I	General hospital	Contract sterilization	May 30, 2023
KZL	Device, Warming. Blood And Plasma	Class II	Hematology	Contract sterilization	Jan 8, 2013
LDF	Electrode, Pacemaker, Temporary	Class II	Cardiovascular	Contract sterilization	Jan 5, 2021
LFL	Instrument, Ultrasonic Surgical	Unclassified	General and plastic surgery	Contract sterilization	Mar 24, 2023
LGZ	Warmer, Thermal, Infusion Fluid	Class II	General hospital	Contract sterilization	Jan 8, 2013
LHI	Set, I.V. Fluid Transfer	Class II	General hospital	Contract sterilization	Nov 5, 2012
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	Class II	General hospital	Contract sterilization	Jan 8, 2013
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unclassified	Gastroenterology and urology	Contract sterilization	Dec 12, 2013
LLD	Port & Catheter, Implanted, Subcutaneous, Intraperitoneal	Class II	General hospital	Contract sterilization	Dec 29, 2015
LPB	Cardiac Ablation Percutaneous Catheter	Class III	Cardiovascular	Contract sterilization	Jan 5, 2021
LPL	Lenses, Soft Contact, Daily Wear	Class II	Ophthalmic	Contract sterilization	Jul 10, 2023
MEA	Pump, Infusion, Pca	Class II	General hospital	Contract sterilization	Jan 8, 2013
MJN	Catheter, Intravascular Occluding, Temporary	Class II	Cardiovascular	Contract sterilization	Jul 10, 2023
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract sterilization	Jul 11, 2023
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract sterilization	Jul 11, 2023
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract sterilization	Jul 11, 2023
MQX	Needle, Acupuncture, Single Use	Class II	General hospital	Contract sterilization	Jul 10, 2023
MRZ	Accessories, Pump, Infusion	Class II	General hospital	Contract sterilization	Sep 20, 2023
MTD	Catheter, Intracardiac Mapping, High-Density Array	Class II	Cardiovascular	Contract sterilization	Jan 5, 2021
MVN	Lens, Contact, (Disposable)	Class II	Ophthalmic	Contract sterilization	Jul 10, 2023
NAY	System, Surgical, Computer Controlled Instrument	Class II	Gastroenterology and urology	Contract sterilization	Jun 22, 2023
NHK	Resuscitator, Manual, Non Self-Inflating	Class II	Anesthesiology	Contract sterilization	Oct 11, 2019
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract sterilization	Jul 12, 2023
NLF	Oximeter, Reprocessed	Class II	Cardiovascular	Contract sterilization	Dec 17, 2012
NLG	Catheter, Intracardiac Mapping, High-Density, Reprocessed	Class II	Cardiovascular	Contract sterilization	Aug 17, 2023
NLH	Catheter, Recording, Electrode, Reprocessed	Class II	Cardiovascular	Contract sterilization	Apr 26, 2013
NMK	Trocar, Reprocessed	Class II	Cardiovascular	Contract sterilization	Aug 17, 2023
NQP	Posterior Metal/Polymer Spinal System, Fusion	Class II	Orthopedic	Contract sterilization	Jul 12, 2023
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	Class II	General and plastic surgery	Contract sterilization	Jun 24, 2013
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Class III	Cardiovascular	Contract sterilization	Jan 5, 2021
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Class III	Cardiovascular	Contract sterilization	Jan 5, 2021
OBJ	Catheter, Ultrasound, Intravascular	Class II	Cardiovascular	Contract sterilization	Aug 31, 2023
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	Class II	General hospital	Contract sterilization	Dec 2, 2018
OPE	Product code OPE (not in FDA's classification file)	–	–	Contract sterilization	Jul 10, 2023
OWQ	Reprocessed Intravascular Ultrasound Catheter	Class II	Cardiovascular	Contract sterilization	Apr 26, 2013
PCB	External Cerebrospinal Fluid (Csf) Diversion	Class II	Neurology	Contract sterilization	Jun 19, 2023
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Class II	Gastroenterology and urology	Contract sterilization	May 30, 2023
PNE	Reprocessed Catheter Introducer	Class II	Cardiovascular	Contract sterilization	Aug 17, 2023
PPG	Urinary Drainage Collection Kit	Class II	Gastroenterology and urology	Contract sterilization	May 30, 2023
PUI	Drape, Surgical, Exempt	Class II	General and plastic surgery	Contract sterilization	Aug 1, 2023
PWH	Administrations Sets With Neuraxial Connectors	Class II	General hospital	Contract sterilization	Mar 7, 2019
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Class III	Cardiovascular	Contract sterilization	Apr 2, 2026

Isomedix Operations Inc.

Devices listed as contract work

Other contract facilities of STERIS Corporation