Medical Device Manufacturer · US , Mentor , OH

Steris - FDA 510(k) Cleared Devices

20 submissions · 19 cleared · Since 2021
20
Total
19
Cleared
1
Denied

FDA 510(k) cleared devices by Steris General Hospital

16 devices
1-16 of 16
Cleared Jun 06, 2025
Celerity 5 HP Biological Indicator (LCB052)
K251452 · FRC
General Hospital · 28d
Not Cleared Nov 12, 2024
VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
DEN230085 · SDC
General Hospital · 330d
Cleared Aug 20, 2024
CELERITY HP Indicator Tape (PCC077)
K242189 · JOJ
General Hospital · 26d
Cleared Jun 11, 2024
MetriCide™ OPA Plus Solution Test Strip
K241344 · JOJ
General Hospital · 29d
Cleared Apr 10, 2024
CELERITY HP Indicator Tape
K240760 · JOJ
General Hospital · 21d
Cleared Dec 08, 2023
VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical...
K233654 · JOJ
General Hospital · 24d
Cleared Oct 27, 2023
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
K233187 · JOJ
General Hospital · 29d
Cleared Oct 20, 2023
V-PRO maX 2 Low Temperature Sterilization System
K233065 · MLR
General Hospital · 24d
Cleared Sep 13, 2023
AMSCO 600 Steam Sterilizer
K232485 · FLE
General Hospital · 28d
Cleared Aug 07, 2023
Celerity™ HP Chemical Indicator
K231488 · JOJ
General Hospital · 76d
Cleared Sep 30, 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization...
K222849 · NVE
General Hospital · 9d
Cleared Sep 09, 2022
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature...
K222093 · MLR
General Hospital · 56d
Cleared Sep 09, 2022
Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE...
K222440 · FRG
General Hospital · 28d
Cleared Aug 25, 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization...
K222543 · NVE
General Hospital · 3d
Cleared Mar 18, 2022
CELERITY 20 HP Challenge Pack
K220473 · FRC
General Hospital · 28d
Cleared Jan 28, 2021
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K203223 · NZA
General Hospital · 87d
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