12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EchoGo Heart Failure
FDA 510(k)
FDA Class 2
·Cardiovascular
HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD
FDA UDI
Medos International Sàrl·10886705030927·HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures ...
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 15, 2024
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·June 27, 2006
APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W
FDA 510(k)
FDA Class 2
·Orthopedic
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN ASR HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWY·November 4, 2008
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 13, 2011
LEAD MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 12, 2013
BD KIESTRA IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025
BD KIESTRA¿ IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·December 9, 2024
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025