STERIS Corporation - FDA 510(k) Cleared Devices
204
Total
202
Cleared
2
Denied
204 devices
Cleared
Jul 25, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
Gastroenterology & Urology
29d
Cleared
Jul 21, 2023
enspire 300 Series Automated Endoscope Reprocessor System
General Hospital
143d
Cleared
Jul 17, 2023
Revital-Ox PAA High Level Disinfectant Chemical Indicator
General Hospital
139d
Cleared
Jun 30, 2023
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
General Hospital
88d
Cleared
Jun 15, 2023
Celerity Incubator
General Hospital
195d
Cleared
Jun 15, 2023
Celerity 5 HP Biological Indicator
General Hospital
185d
Cleared
Mar 28, 2023
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
General Hospital
26d
Cleared
Feb 17, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
Gastroenterology & Urology
92d
Cleared
Dec 02, 2022
truFreeze Console, PN CC301
General & Plastic Surgery
28d
Cleared
Sep 28, 2022
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
General Hospital
29d
Cleared
Aug 18, 2022
truFreeze Console, PN CC301
General & Plastic Surgery
20d
Cleared
Jul 21, 2022
Celerity Incubator
General Hospital
220d
Cleared
Mar 11, 2022
EndoGator Endoscopy Irrigation Tubing
Gastroenterology & Urology
28d
Cleared
Mar 10, 2022
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
General Hospital
30d
Cleared
Jan 07, 2022
CELERITY HP Chemical Indicator
General Hospital
99d
Cleared
Nov 23, 2021
Uretero1 Ureteroscope System
Gastroenterology & Urology
204d
Cleared
Oct 28, 2021
AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
General Hospital
85d
Cleared
Oct 07, 2021
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack...
Gastroenterology & Urology
29d
Cleared
Sep 07, 2021
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
General Hospital
105d
Cleared
Sep 03, 2021
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing,...
Gastroenterology & Urology
210d
Cleared
Aug 25, 2021
AMSCO 600 Medium Steam Sterilizer
General Hospital
103d
Cleared
May 12, 2021
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
General Hospital
62d
Cleared
Jan 14, 2021
BioGuard EUS Air/Water and Suction Valves
Gastroenterology & Urology
169d
Cleared
Jan 08, 2021
Celerity 20 Steam Biological Indicator for IUSS
General Hospital
113d
Cleared
Dec 01, 2020
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP...
General Hospital
33d
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