22 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ENDIUS CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140070·T-Handle, T30, Locking Cap Adjuster
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101070·Distractor, Smooth Paddle, Lordotic, 7mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101070·Distractor, Smooth Paddle, 7mm
SPARE PAIR
FDA UDI
FGX INTERNATIONAL INC.·00887661644275·
SPARE PAIR
FDA UDI
FGX INTERNATIONAL INC.·00887661644268·
NA
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·March 7, 2012
R STENT BILIARY ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO SOLO
FDA 510(k)
FDA Class 2
·Physical Medicine
ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·April 25, 2014
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·November 2, 2017
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 10, 2011
CARPENTIER EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
FDA Adverse Event
Other
·EDWARDS LIFESCIENCES·Product code KRH·March 12, 2008
ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·April 25, 2014
MELODY TRANSCATHER PULMONARY
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPV·February 5, 2015
MELODY TRANSCATHER PULMONARY
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPV·February 5, 2015
VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA
FDA Adverse Event
Malfunction
·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020
MELODY TRANSCATHER PULMONARY
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPV·February 5, 2015
DELTA DUAL MOBILITY SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LZO·July 18, 2024