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
76-100 of 173
Cleared Feb 09, 2018
V-PRO maX 2 Low Temperature Sterilization System
K172754 · MLR
General Hospital · 150d
Cleared Feb 09, 2018
PRO-LITE Sterilization Trays
K172755 · KCT
General Hospital · 150d
Cleared Jan 18, 2018
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low...
K172319 · MLR
General Hospital · 170d
Cleared Dec 29, 2017
Celerity 20 HP Biological Indicator
K172474 · FRC
General Hospital · 136d
Cleared Nov 17, 2017
Micro-MEC 1.8% Glutaraldehyde Monitor Strip
K172472 · JOJ
General Hospital · 94d
Cleared Sep 22, 2017
SYSTEM 1E Liquid Chemical Sterilant Processing System
K170956 · MED
General Hospital · 175d
Cleared Aug 22, 2017
VERIFY Assert VH2O2 Self-Contained Biological Indicator
K171504 · FRC
General Hospital · 91d
Cleared Aug 22, 2017
VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
K171587 · FRC
General Hospital · 83d
Cleared Apr 28, 2017
VERIFY ASSERT STEAM Process Challenge Device
K162945 · OWP
General Hospital · 189d
Cleared Apr 28, 2017
VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles
K170070 · FRC
General Hospital · 109d
Cleared Mar 31, 2017
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low...
K162413 · MLR
General Hospital · 214d
Cleared Mar 24, 2017
VERIFY Assert Self-Contained Biological Indicator
K162701 · OWP
General Hospital · 177d
Cleared Mar 24, 2017
VERIFY Incubator for Assert Self Contained Biological Indicators
K163587 · OWP
General Hospital · 94d
Cleared Mar 21, 2017
VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY...
K162758 · JOJ
General Hospital · 172d
Cleared Jan 27, 2017
VERIFY STEAM Integrating Indicator - Short
K162631 · JOJ
General Hospital · 128d
Cleared Oct 07, 2016
Sterilization Tray
K160912 · KCT
General Hospital · 189d
Cleared Aug 05, 2016
SYSTEM 1E Liquid Chemical Sterilant Processing System
K161683 · MED
General Hospital · 49d
Cleared Jul 22, 2016
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K160908 · FRG
General Hospital · 112d
Cleared Jul 06, 2016
V-PRO® 1 Plus and V-PRO® maX Low Temperature
K160433 · MLR
General Hospital · 141d
Cleared Jun 01, 2016
VERIFY VH2O2 Indicator Tape
K160485 · JOJ
General Hospital · 100d
Cleared May 12, 2016
VERIFY STEAM Integrating Indicator
K152630 · JOJ
General Hospital · 240d
Cleared Apr 14, 2015
Revital-Ox RESERT Solution Test Strip
K143333 · JOJ
General Hospital · 145d
Cleared Jul 25, 2014
V-PRO STERILIZATION TRAY/ STERILIZATION MAT
K140494 · KCT
General Hospital · 148d
Cleared Jul 24, 2014
V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
K140498 · MLR
General Hospital · 147d
Cleared Jul 22, 2014
VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
K140487 · FRG
General Hospital · 145d

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