Cook Ireland, Ltd.
Dispositifs autorisés FDA 510(k) et PMA — 16 produits
Publicité
Nombre total de dispositifs16
Catégories0
Dernière décision de la FDA
| Type | Numéro | Nom du dispositif | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | KTI | 2026-07-24 | Voir |
| 510(k) | K241209 | EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) | FCG | 2024-07-29 | Voir |
| 510(k) | K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) | FGE | 2024-06-14 | Voir |
| 510(k) | K230909 | EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) | FCG | 2023-05-30 | Voir |
| 510(k) | K213946 | Compass BDS Biliary Stent | FGE | 2022-05-09 | Voir |
| 510(k) | K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle | FCG | 2021-05-20 | Voir |
| 510(k) | K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | FGE | 2018-11-16 | Voir |
| 510(k) | K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set | FGE | 2018-03-09 | Voir |
| 510(k) | K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S | FGE | 2018-02-27 | Voir |
| 510(k) | K171619 | 14Fr Colon Decompression Set, Macon Colon Decompression Set | FEG | 2017-08-01 | Voir |
| 510(k) | K171623 | Nasal Pancreatic Drainage Set | FGE | 2017-07-31 | Voir |
| 510(k) | K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | MUM | 2017-05-04 | Voir |
| 510(k) | K163169 | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent | FGE | 2017-02-07 | Voir |
| 510(k) | K163018 | Zilver 635 Biliary Stent | FGE | 2016-12-23 | Voir |
| 510(k) | K162717 | Evolution Esophageal Stent System – Partially Covered | ESW | 2016-12-21 | Voir |
| 510(k) | K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle | FCG | 2016-03-21 | Voir |
Aucun dispositif correspondant.