17 results
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20ms
·
Sources: EU EUDAMED, US FDA
T1D1
FDA 510(k)
FDA Class 2
·Anesthesiology
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124092·Modular Offset Stem 11mm x 100mm x 4mm
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112731·BARRON VACUUM PUNCH 7.0MM
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306825262·Scherback Speculum Blade, 8.5cm x 3.5cm Cup Blade
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252104200·ceraMotion® Me Base Dentin Modifier ivory, 20 g...
ENDURANCE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295127949·ENDURANCE BROACH SIZE 4
BioGuard EUS Air/Water and Suction Valves
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOQTEQ®
FDA UDI
aap Implantate AG·04042409363184·LOQTEQ® VA Volar Distal Radius Plate 2.5, broad...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
PRIMARY ADMINISTARTION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·April 25, 2014
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
JAGWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code EZB·December 4, 2008
VICRYL (POLYGLACTIN 910) MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·September 16, 2011
ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·July 29, 2013
BD AUTOSHIELD DUO PEN NEEDLE 30GX5MM
FDA Adverse Event
Injury
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMI·June 30, 2016
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Recall
Open, Classified
·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025