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Dispositifs autorisés FDA 510(k) et PMA — 19 produits
Publicité
Nombre total de dispositifs19
Catégories0
Dernière décision de la FDA
| Type | Numéro | Nom du dispositif | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251452 | 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 | 2025-06-06 | Voir |
| 510(k) | K242773 | Electro Lube NXT | GEI | 2025-04-15 | Voir |
| 510(k) | K242189 | CELERITY HP Indicator Tape (PCC077) | JOJ | 2024-08-20 | Voir |
| 510(k) | K241344 | MetriCide™ OPA Plus Solution Test Strip | JOJ | 2024-06-11 | Voir |
| 510(k) | K241055 | Electro Lube NXT | GEI | 2024-05-31 | Voir |
| 510(k) | K240760 | CELERITY HP Indicator Tape | JOJ | 2024-04-10 | Voir |
| 510(k) | K232826 | 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) | FBK | 2024-03-08 | Voir |
| 510(k) | K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | JOJ | 2023-12-08 | Voir |
| 510(k) | K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | JOJ | 2023-10-27 | Voir |
| 510(k) | K232951 | 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) | ODC | 2023-10-20 | Voir |
| 510(k) | K233065 | V-PRO maX 2 Low Temperature Sterilization System | MLR | 2023-10-20 | Voir |
| 510(k) | K232485 | AMSCO 600 Steam Sterilizer | FLE | 2023-09-13 | Voir |
| 510(k) | K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape | JOJ | 2023-08-07 | Voir |
| 510(k) | K222849 | 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 Disinfector | NVE | 2022-09-30 | Voir |
| 510(k) | K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System | MLR | 2022-09-09 | Voir |
| 510(k) | K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays | FRG | 2022-09-09 | Voir |
| 510(k) | K222543 | 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 Disinfector | NVE | 2022-08-25 | Voir |
| 510(k) | K220473 | CELERITY 20 HP Challenge Pack | FRC | 2022-03-18 | Voir |
| 510(k) | K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | NZA | 2021-01-28 | Voir |
Aucun dispositif correspondant.