STERIS Corporation
FDA 510(k) & PMA Approved Devices — 120 products
Total Devices120
Categories23
Latest FDA decision2026-06-24
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261055 | AMSCO 700 Steam Sterilizer | FLE | 2026-06-24 | View |
| 510(k) | K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | 2026-04-08 | View |
| 510(k) | K260766 | Celerity 5 HP Biological Indicator (LCB052) | FRC | 2026-04-08 | View |
| 510(k) | K252680 | Celerity™ 20 HP Biological Indicator | FRC | 2025-09-24 | View |
| 510(k) | K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | JOJ | 2025-05-02 | View |
| 510(k) | K243876 | VERIFY STEAM Integrating Indicator | JOJ | 2025-04-25 | View |
| 510(k) | K250842 | PADLOCK CLIP EFTR Kit (00713229) | PKL | 2025-04-18 | View |
| 510(k) | K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | FRC | 2025-02-06 | View |
| 510(k) | K250061 | Celerity Incubator | FRC | 2025-02-06 | View |
| 510(k) | K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | JOJ | 2024-12-04 | View |
| 510(k) | K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | FEB | 2024-12-02 | View |
| 510(k) | K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) | ODC | 2024-11-08 | View |
| 510(k) | K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | ODC | 2024-10-11 | View |
| 510(k) | K240274 | PADLOCK CLIP EFTR Kit (00713229) | PKL | 2024-09-17 | View |
| 510(k) | K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | JOJ | 2024-04-17 | View |
| 510(k) | K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | ODC | 2024-03-06 | View |
| 510(k) | K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | ODC | 2024-02-09 | View |
| 510(k) | K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | OVY | 2023-12-15 | View |
| 510(k) | K233681 | ConFirm 20 Minute Incubator | FRC | 2023-12-15 | View |
| 510(k) | K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | MED | 2023-10-03 | View |
No matching devices.
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