Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032112

FEI Number

3003076831

Entity Name

Isomedix Operations Inc.

City/State/Country

SAN DIEGO, CA, US

Establishment Address

7685 ST.ANDREWS AVE., SAN DIEGO, CA 92154, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 9072619)

Owner / Operator Contact Address

5960 Heisley Road, --, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter Haemonetics2300 (SDA) - MCS+ Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter Carefusion (SDA) - Set, administration, intravascular Innovative7777 (SDA) - Reprocessed Diagnostic Ultrasound Catheter StrykerSustainability (SDA) - Reprocessed Electrophysiology Catheters Jabil3944 (SDA) - HAND CONTROLLER KIT, CARTON, US, ATX-ACIST Jabil3944 (SDA) - PREMIUM HAND CONTROL KIT, US, DEHP FREE TUBING, STERILIZED Jabil3944 (SDA) - PREMIUM HAND CONTROL KIT, COEX, STERILIZED Carefusion5709 (SDA) - Alaris Extension Set- Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical Innovative7777 (SDA) - Reprocessed Mapping Catheter Sensor Enabled Intuitive5779 (SDA,GP) - Si Harmonic ACE Insert StrykerSustainability6623 (SDA) - Reprocessed Intravascular Ultrasound Catheter Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter StrykerSustainability (SDA) - Reprocessed External Fixation Devices StrykerSustainability (SDA) - Reprocessed Intravascular Ultrasound Catheter StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Cable Intuitive5779 (SDA,GP) - IS4200 Arm 4 Proximal Drape Protech3048 (GP) - 7894-6 - LEVO STERILE CERVICAL DRAPE W/WINDOW 6CS Protech3048 (GP) - 6855AUD-6 - HANA ANTERIOR HIP UPPER STERILE DRAPE, 6 Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Catheter Innovative7777 (SDA) - Reprocessed AcuNav Diagnostic Ultrasound Catheter StrykerSustainability (SDA) - Reprocessed External Fixation Devices Innovative7777 (SDA) - Reprocessed Mapping Catheter Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter StrykerSustainability (SDA) - Reprocessed External Fixation Devices Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical Ethicon (SDA,GP) - Staple, Implantable Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical Ethicon (SDA) - Electrosurgical, Cutting & Coagulation & Accessories Ethicon (SDA,GP) - Surgical Stapler StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Catheter StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Catheter StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Catheter StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Cable Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter Innovative7777 (SDA) - Reprocessed Transseptal Needle StrykerSustainability (SDA) - Reprocessed External Fixation Devices StrykerSustainability6623 (SDA) - Reprocessed Catheter and Cable StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Catheter Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Catheter StrykerSustainability6623 (SDA) - Reprocessed Catheter and Cable Carefusion5709 (SDA) - MedSystem III Infusion Set Haemonetics (SDA) - PCS Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter Innovative7777 (SDA) - Reprocessed Steerable Introducer Haemonetics (SDA) - CELL SAVER Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter Haemonetics (SDA) - CELL SAVER ELITE Medtronic4423 (SDA) - Becker External Drainage and Monitoring System Haemonetics (SDA) - MCS+ Innovative7777 (SDA) - Reprocessed Electrophysiology Catheter StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Catheter StrykerSustainability6623 (SDA) - Reprocessed EP Catheter and Cable StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Cable Medtronic4423 (SDA) - DUET External Drainage And Monitoring System Haemonetics (SDA) - CYMBAL, MCS+ Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical Intuitive_5779 (SDA,GP) - Stapler Reload SureForm 60 Intuitive_5779 (SDA,GP) - Stapler SureForm 45 Curved-Tip Intuitive_5779 (SDA,GP) - Stapler Reload SureForm 45 Intuitive_5779 (SDA,GP) - Stapler SureForm 45 Straight-Tip Intuitive_5779 (SDA,GP) - Stapler SureForm 60 Instrument Intuitive_5779 (SDA,GP) - Stapler Reload SureForm 45 (Grey) Intuitive_5779 (SDA,GP) - Xi Stapler 30 Reload Intuitive5779 (SDA,GP) - Xi Column Drape Intuitive5779 (SDA,GP) - Xi Instrument Arm Drape StrykerSustainability (SDA) - Reprocessed External Fixation Devices Intuitive5779 (SDA,GP) - Xi Single-Site Cannula Seal Intuitive5779 (SDA,GP) - Xi Single-Site Port Intuitive5779 (SDA,GP) - Xi Single Site Bipolar Maryland Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter StrykerSustainability6623 (SDA) -Reprocessed Electrode Recording Catheter StrykerSustainability6623 (SDA) - Reprocessed Catheter and Cable StrykerSustainability6623 (SDA) - Reprocessed EP Catheter and Cable StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Cable Intuitive_5779 (SDA,GP) - Xi Vessel Sealer Extend Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter StrykerSustainability (SDA) - Reprocessed External Fixation Devices StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Catheter Innovative7777 (SDA) - Reprocessed Diagnostic Ultrasound Catheter Nellcor9703 (CH2) - Covidien LLC Haemonetics (SDA) - PCS Intuitive5779 (SDA,GP) - Xi Harmonic ACE Jabil3944 (SDA) - PREMIUM HAND CONTROL KIT, US, DEHP FREE TUBING, STERILIZED Jabil3944 (SDA) - PREMIUM HAND CONTROL KIT, HTP, STERILIZED Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter Intuitive5779 (SDA,GP) - Stapler Sheath Intuitive5779 (SDA,GP) - MCS Tip Cover Medtronic4423 (SDA) - Exacta External Drainage and Monitoring System Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter StrykerSustainability6623 (SDA) - Reprocessed Intravascular Ultrasound Catheter Intuitive5779 (GP,SDA) - Xi Stapler 45 Reload Intuitive5779 (SDA,GP) - Xi 8mm Synchroseal Intuitive_5779 (SDA,GP) - 8mm Stapler Ethicon (SDA,GP) - ETHICON 4000 Medtronic4423 (SDA) - PS MEDICAL CSF-LUMBOPERITONEAL SHU Haemonetics (SDA) - ACP215 Haemonetics (SDA) - RIS StrykerSustainability (SDA) - Reprocessed EP Catheter Medtronic4423 (SDA) - PS MEDICAL CSF-FLOW CONTROL VALVE StrykerSustainability (SDA) - Reprocessed External Fixation Devices StrykerSustainability6623 (SDA) - Electrode Cable Innovative7777 (SDA) - CABLE, ELECTRODE Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical CodanUS3940 (SDA) - BBG Carefusion5709 (SDA) - Alaris Syringe Module Syringe Administration Set BiosenseWebster3941 (SDA,GP) - Interface Cable Ethicon (SDA,GP) - ETHICONTM 4000 45mm Stapler Intuitive5779 (SDA,GP) - 19G Biopsy Needle Intuitive5779 (SDA,GP) - Vision Probe Adapter Intuitive5779 (SDA,GP) - 21G Biopsy Needle Intuitive5779 (SDA,GP) - 23GBiopsy Needle Intuitive5779 (SDA,GP) - Swivel Connector StrykerSustainability (SDA) - Reprocessed EP Catheters Intuitive_5779 (SDA,GP) - SP Instrument Sheath Intuitive_5779 (SDA,GP) - SP Camera Instrument Sheath Intuitive_5779 (SDA,GP) - SP Monopolar Scissors Tip Innovative7777 (SDA) - Reprocessed Mapping Diagnostic Electrophysiology Catheter Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical Ethicon (SDA,GP) - Electrosurgical, Cutting & Coagulation & Accessories Haemonetics (SDA) - MCS+ Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2013-12-12
BZW	Stethoscope, Esophageal	Anesthesiology	Class 1	868.1910	2013-01-08
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2020-03-02
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2024-07-31
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2023-07-10
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-18
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2018-02-13
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2023-08-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-01-08
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2012-11-06
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2021-01-05
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2023-05-30
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-07-11
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-07-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-07-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-01-08
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2015-11-28
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2023-12-14
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2015-11-24
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2023-05-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-18
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
NLG	Catheter, Intracardiac Mapping, High-Density, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
EFA	Handpiece, Belt And/Or Gear Driven, Dental	Dental	Class 1	872.4200	2023-07-12
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2013-04-26
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-11-06
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-04-26
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-12-17
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2013-04-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-01-08
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-06-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-01-08
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2012-11-06
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2023-08-01
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2013-01-08
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2013-01-29
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2013-01-29
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2023-05-30
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2013-04-26
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2023-07-10
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2023-08-17
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2013-04-26
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2013-04-26
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-04-26
NLG	Catheter, Intracardiac Mapping, High-Density, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2012-11-06
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2021-01-05
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2020-11-11
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2018-02-13
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-04-26
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2023-07-10
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2023-05-31
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-12-17
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2013-01-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-03-24
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2023-07-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-09-25
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2024-09-25
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2012-11-06
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2023-07-10
OPE	N/A	N/A	Class N/A	N/A	2023-07-10
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2013-04-26
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-01-08
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-05-31
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2020-11-11
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-07-10
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-11-05
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2025-11-25
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2023-05-30
NMK	Trocar, Reprocessed	Cardiovascular	Class 2	870.1390	2023-08-17
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2013-04-26
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-04-26
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2013-04-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-12-17
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2012-12-17
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-12-17
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2012-12-17
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2018-12-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-12-02
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2023-05-30
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-11-05
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2013-04-26
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-09-25
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2014-09-25
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2023-07-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-12-28
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2018-12-02
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2018-02-13
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2023-05-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-29
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2015-11-28
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-12-28
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2019-03-07
PWH	Administrations Sets With Neuraxial Connectors	General Hospital	Class 2	880.5440	2019-03-07
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2012-11-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-11-28
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2023-05-30
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2026-04-02
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2021-01-05
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-07-10
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2021-01-05
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-12-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-11-05
PNE	Reprocessed Catheter Introducer	Cardiovascular	Class 2	870.1340	2023-08-17
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2018-12-02
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2023-07-11
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2018-02-14
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-11-05
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2023-07-12
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-01-08
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2013-01-08
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2023-07-10
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2013-01-08
EXR	Urinometer, Mechanical	Gastroenterology, Urology	Class 2	876.1800	2023-05-31
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2024-07-31
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2013-12-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-07-11
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2013-01-08
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2023-06-19
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2012-12-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2013-12-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-11-06
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-11-06
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2012-12-17
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2012-12-17
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-11-06
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-01-08
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2018-12-02
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2018-12-02
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-12-17
PCB	External Cerebrospinal Fluid (Csf) Diversion	Neurology	Class 2	882.5560	2023-06-19
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2013-12-12
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2012-12-20
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2019-10-11
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-10-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-10-30
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2024-10-30
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-12-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-11-11
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-01-08
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-04-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2023-07-10
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2018-12-02
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-12-02
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2018-12-02
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2026-04-02
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-07-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-05-05
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2013-01-08
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2013-01-08
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-01-08
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-10-30
KSW	System, Processing For Frozen Blood	Hematology	Class 2	864.9145	2018-02-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2018-12-02
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2013-04-26
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2013-04-26
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-04-26
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2025-11-24
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2012-12-17
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2023-08-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-07-11
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-07-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-31
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2015-11-30
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2012-11-06
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2018-02-13
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-06-22
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2023-12-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-01-08
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-07-10
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-07-31
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-07-11
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2012-12-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-01-08
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2023-08-31
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-06-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-05-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-11-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-01-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
HCA	Catheter, Ventricular	Neurology	Class 2	882.4100	2023-06-19
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2023-06-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-11-11
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2013-04-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-11-05
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-03-10
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-01-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-22
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2012-11-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-10-11
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-10-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-10-30
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2023-05-30
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2024-10-31
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-10-31
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2023-06-19
KZL	Device, Warming. Blood And Plasma	Hematology	Class 2	864.9205	2013-01-08
LLD	Port & Catheter, Implanted, Subcutaneous, Intraperitoneal	General Hospital	Class 2	880.5965	2015-12-29
KSW	System, Processing For Frozen Blood	Hematology	Class 2	864.9145	2013-12-12
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2021-01-05
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2012-11-05
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2018-02-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-11-05
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-01-08
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-07-10
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2023-06-19
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2012-12-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2012-12-17
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2013-01-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2013-06-24
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2016-11-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-11-15
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-04-26
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2013-04-26
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2023-05-30
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2023-05-30
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2023-05-31
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-18
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-07-10
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2012-11-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-12-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-12-17
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2023-07-12
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2021-01-05
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2021-01-05
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2021-01-05
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2012-11-05
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-01-08
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2025-12-23
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-12-23
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-01-08
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2012-12-17
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-06-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2015-12-29
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2013-04-26
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2023-09-20
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-06-22
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-06-21
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2024-07-31
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2023-05-30
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-11-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-11-11
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-07-10
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2021-01-05
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-01-05
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2021-01-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-08
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2023-03-24
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-03-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-03-24
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2013-12-12
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	Class 2	870.1220	2023-08-17
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2026-04-02
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2018-12-02

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 Recall Records

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Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032112. Last updated year: 2026. Please use registration number 2032112 when referencing this establishment in official correspondence.