9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Myocardial Strain Software Application
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101162·DLEK CORNEAL DISSECTOR, VAULTED
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIGHTSCALPEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·November 6, 2014
ASR UNI FEMORAL IMPL SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 18, 2011
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025