22 results
·
29ms
·
Sources: EU EUDAMED, US FDA
SYSMEX UF-50
FDA 510(k)
FDA Class 2
·Hematology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673181·LEVAMED STABILI-TRI ANK BLU R II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673143·LEVAMED STABILI-TRI ANK SUP BLU L II
G-aenial™
FDA UDI
Gc America Inc.·14548161328647·G-aenial Universal Injectable CVD, Dispensing T...
G-aenial™
FDA UDI
Gc America Inc.·D0470123721·G-aenial Universal Injectable CVD, Dispensing T...
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033390788·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033390757·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033390719·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033390771·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033390603·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033390733·
LIGHTLAS 532 PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
ACCESS ALERT GAUGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 8, 2025
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013
INTERTAN
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, INC.·Product code JDS·March 9, 2011
INTELECT XT
FDA Adverse Event
Other
·CHATTANOOGA GROUP·Product code IPF·March 7, 2008
CARDIOSAVE HYBRID
FDA Adverse Event
Injury
·DATASCOPE CORP. - MAHWAH·Product code DSP·June 11, 2020
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·January 16, 2013