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Cook Ireland, Ltd. FDA Approvals
0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes510(k)Jul 24, 2026Ear, Nose, Throat |
| EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)510(k)Jul 29, 2024Gastroenterology, Urology |
| 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)510(k)Jun 14, 2024Gastroenterology, Urology |
| EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)510(k)May 30, 2023Gastroenterology, Urology |
| Compass BDS Biliary Stent510(k)May 9, 2022Gastroenterology, Urology |
| 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 Needle510(k)May 20, 2021Gastroenterology, Urology |