10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INJECTION NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
FDA 510(k)
FDA Class 2
·Orthopedic
Tiger Cannulated Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
DRIVING CAP/THREADED
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·August 26, 2019
SPRINT QUATTRO
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LWS·February 9, 2013
SYNCHRON LX® I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·January 8, 2011
UNKNOWN DEPUY POLY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code KWA·July 23, 2014
VERSYS FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·February 25, 2016
DRIVING CAP/THREADED
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code LXH·November 21, 2016
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026