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Cook Ireland, Ltd.

FDA 510(k) & PMA Approved Dispositivos — 16 products

Total de dispositivos16
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K261274 EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesKTI2026-07-24 Ver
510(k) K241209 EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)FCG2024-07-29 Ver
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)FGE2024-06-14 Ver
510(k) K230909 EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG2023-05-30 Ver
510(k) K213946 Compass BDS Biliary StentFGE2022-05-09 Ver
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 NeedleFCG2021-05-20 Ver
510(k) K182980 Zilver 518 Biliary Stent, Zilver 635 Biliary StentFGE2018-11-16 Ver
510(k) K172057 Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer SetFGE2018-03-09 Ver
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 SFGE2018-02-27 Ver
510(k) K171619 14Fr Colon Decompression Set, Macon Colon Decompression SetFEG2017-08-01 Ver
510(k) K171623 Nasal Pancreatic Drainage SetFGE2017-07-31 Ver
510(k) K163468 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredMUM2017-05-04 Ver
510(k) K163169 Zilver 518TM Biliary Stent; Zilver 635TM Biliary StentFGE2017-02-07 Ver
510(k) K163018 Zilver 635 Biliary StentFGE2016-12-23 Ver
510(k) K162717 Evolution Esophageal Stent System – Partially CoveredESW2016-12-21 Ver
510(k) K160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy NeedleFCG2016-03-21 Ver
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