Medical Device Manufacturer · US , Mentor , OH

Steris - FDA 510(k) Cleared Devices

24 submissions · 22 cleared · Since 2021

Recent clearances: V-Pro maX 2 Low Temperature Sterilization System, VERIFY RESI-TEST SWAB Protein Detection Indicator, MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor

View 24 510(k) Devices ↓ Official Website

24

Total

22

Cleared

2

Denied

FDA 510(k) Regulatory Record - Steris General Hospital ✕

20 devices

1-12 of 20

Cleared Oct 29, 2026

V-Pro maX 2 Low Temperature Sterilization System

General Hospital · 30d

Cleared Oct 28, 2026

VERIFY RESI-TEST SWAB Protein Detection Indicator

General Hospital · 229d

Cleared Oct 02, 2026

MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor

General Hospital · 126d

Not Cleared May 01, 2026

Prolystica Pass Thru Disinfectant Wipes

DEN240075 · SHM

General Hospital · 505d

Cleared Jun 06, 2025

Celerity 5 HP Biological Indicator (LCB052)

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)

General Hospital · 26d

Cleared Jun 11, 2024

MetriCide™ OPA Plus Solution Test Strip

General Hospital · 29d

Cleared Apr 10, 2024

CELERITY HP Indicator Tape

General Hospital · 21d

Cleared Dec 08, 2023

VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical...

General Hospital · 24d

Cleared Oct 27, 2023

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)

General Hospital · 29d

Cleared Oct 20, 2023

V-PRO maX 2 Low Temperature Sterilization System

General Hospital · 24d