10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TITANALOY SUBMERSIBLE IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TwinFix
FDA UDI
Stryker GmbH·04546540362070·CANNULATED COMPRESSION SCREW
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018
FDA 510(k)
FDA Class 2
·Cardiovascular
GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
ARTICUL/EZE BALL 32 +5 BR
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code LPH·August 25, 2014
PINN MAR NEUT 32IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·August 25, 2014
SINGLE USE 3-LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDR·May 13, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 13, 2012
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 1, 2010
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018