Medical Device Manufacturer · US , Mentor , OH

STERIS Corporation - FDA 510(k) Cleared Devices

202 submissions · 200 cleared · Since 1997
202
Total
200
Cleared
2
Denied
173 devices
126-150 of 173
Cleared Feb 18, 2011
STERILIZATION MATS
K103226 · KCT
General Hospital · 109d
Cleared Feb 09, 2011
VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP...
K102296 · JOJ
General Hospital · 180d
Cleared Dec 03, 2010
RELIANCE ENDOSCOPE PROCESSING SYSTEM
K102244 · NZA
General Hospital · 116d
Cleared Nov 22, 2010
SYSTEM 1E CHEMICAL INDICATOR
K102217 · JOJ
General Hospital · 108d
Cleared Nov 19, 2010
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE,...
K092745 · KCT
General Hospital · 437d
Cleared Sep 21, 2010
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K102462 · MED
General Hospital · 25d
Cleared Aug 02, 2010
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
K101409 · MED
General Hospital · 75d
Cleared Apr 12, 2010
MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
K091022 · MED
General Hospital · 368d
Cleared Apr 05, 2010
SYSTEM 1.5 STERILE PROCESSING SYSTEM
K090036 · MED
General Hospital · 454d
Cleared Dec 30, 2009
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION
K092906 · FRC
General Hospital · 100d
Cleared Dec 18, 2009
AMSCO WARMING CABINET
K092823 · LGZ
General Hospital · 95d
Cleared Nov 04, 2009
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000
K092490 · FLE
General Hospital · 83d
Cleared Oct 27, 2009
VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR
K091174 · JOJ
General Hospital · 188d
Cleared Sep 17, 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K091731 · FLE
General Hospital · 98d
Cleared Sep 01, 2009
VERIFY SCBI 275F 3-10
K083665 · FRC
General Hospital · 265d
Cleared Aug 07, 2009
VERIFY 275F GRAVITY INDICATORS
K083643 · JOJ
General Hospital · 241d
Cleared Aug 03, 2009
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
K083097 · MLR
General Hospital · 290d
Cleared Jun 29, 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200
K091136 · FLE
General Hospital · 70d
Cleared May 01, 2009
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION...
K090371 · KCT
General Hospital · 77d
Cleared Mar 16, 2009
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2)...
K090514 · FRC
General Hospital · 18d
Cleared Jan 07, 2009
VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
K073618 · FRC
General Hospital · 378d
Cleared Dec 30, 2008
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K082435 · FLE
General Hospital · 130d
Cleared Sep 02, 2008
RESERT XL HLD HIGH LEVEL DISINFECTANT
K080420 · MED
General Hospital · 200d
Cleared Aug 22, 2008
STERIS RESERT XL TEST STRIP
K081600 · JOJ
General Hospital · 77d
Cleared Jun 11, 2008
BROWNE OPA TEST STRIP
K081427 · JOJ
General Hospital · 21d

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