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Steris FDA Approvals
0 new drug approvals and 21 device clearances on file. Matched by name to STE.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Prolystica Pass Thru Disinfectant Wipes510(k)May 1, 2026General Hospital |
| Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)510(k)Jun 6, 2025General Hospital |
| Electro Lube NXT510(k)Apr 15, 2025General, Plastic Surgery |
| VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator510(k)Nov 12, 2024General Hospital |
| CELERITY HP Indicator Tape (PCC077)510(k)Aug 20, 2024General Hospital |
| MetriCide OPA Plus Solution Test Strip510(k)Jun 11, 2024General Hospital |
| Electro Lube NXT510(k)May 31, 2024General, Plastic Surgery |
| CELERITY HP Indicator Tape510(k)Apr 10, 2024General Hospital |
| Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)510(k)Mar 8, 2024Gastroenterology, Urology |
| VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems510(k)Dec 8, 2023General Hospital |
| Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)510(k)Oct 27, 2023General Hospital |
| V-PRO maX 2 Low Temperature Sterilization System510(k)Oct 20, 2023General Hospital |
| BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)510(k)Oct 20, 2023Gastroenterology, Urology |
| AMSCO 600 Steam Sterilizer510(k)Sep 13, 2023General Hospital |
| Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape510(k)Aug 7, 2023General Hospital |
| AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector510(k)Sep 30, 2022Gastroenterology, Urology |
| V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System510(k)Sep 9, 2022General Hospital |
| Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays510(k)Sep 9, 2022General Hospital |
| AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector510(k)Aug 25, 2022Gastroenterology, Urology |
| CELERITY 20 HP Challenge Pack510(k)Mar 18, 2022General Hospital |
| Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide510(k)Jan 28, 2021Gastroenterology, Urology |