9 results
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17ms
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Sources: EU EUDAMED, US FDA
PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HEARTRAIL III GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Medline Poly-Cath Red Polymer Urethral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code KNW·March 12, 2026
HOMECHOICE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 15, 2014
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·October 31, 2012
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·June 2, 2015
JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code LWE·October 8, 2025
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015