STERIS Corporation - FDA 510(k) Cleared Devices
202
Total
200
Cleared
2
Denied
173 devices
Cleared
Jan 03, 2019
CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
General Hospital
37d
Cleared
Jan 03, 2019
Vis-U-All Low Temperature Sterilization Pouch/Tubing
General Hospital
37d
Cleared
Jan 03, 2019
PRO-LITE Sterilization Tray
General Hospital
37d
Cleared
Dec 14, 2018
Acu-sInQ Complete Endoscope Cleaning Aid System
General Hospital
155d
Cleared
Dec 10, 2018
CelerityTM 10 STEAM Chemical Indicator
General Hospital
73d
Cleared
Jul 24, 2018
CELERITY 20 Steam Biological Indicator
General Hospital
28d
Cleared
Jun 13, 2018
CELERITY 20 HP Biological Indicator
General Hospital
12d
Cleared
Jun 13, 2018
VERIFY Assert Self-Contained Biological Indicator
General Hospital
12d
Cleared
May 29, 2018
VERIFY Spore Test Strip for S40 Sterilant
General Hospital
89d
Cleared
Mar 09, 2018
Amsco Evolution Medium Steam Sterilizer
General Hospital
116d
Cleared
Mar 02, 2018
System 1 endo Liquid Chemical Sterilant Processing System
General Hospital
143d
Cleared
Mar 02, 2018
VERIFY Chemical Indicator for S40 Sterilant
General Hospital
120d
Cleared
Mar 01, 2018
CELERITY 20 HP Challenge Pack
General Hospital
108d
Cleared
Feb 28, 2018
VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable...
General Hospital
96d
Cleared
Feb 23, 2018
Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000
General Hospital
102d
Cleared
Feb 22, 2018
Amsco Evolution Medium Steam Sterilizer
General Hospital
101d
Cleared
Feb 22, 2018
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
General Hospital
101d
Cleared
Feb 21, 2018
Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
General Hospital
89d
Cleared
Feb 21, 2018
CELERITY 20 Steam Process Challenge Device for Gravity Cycles
General Hospital
89d
Cleared
Feb 12, 2018
CELERITY 20 Steam Biological Indicator
General Hospital
80d
Cleared
Feb 12, 2018
CELERITY 20 Steam Incubator
General Hospital
74d
Cleared
Feb 09, 2018
VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator...
General Hospital
150d
Cleared
Feb 09, 2018
Vis-U-All Low Temperature Sterilization Pouch/Tubing
General Hospital
150d
Cleared
Feb 09, 2018
CELERITY 20 HP Biological Indicator
General Hospital
150d
Cleared
Feb 09, 2018
VERIFY VH2O2 Indicator Tape
General Hospital
150d
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