12 results
·
32ms
·
Sources: EU EUDAMED, US FDA
CALBIOCHEM-BEHRING RIA-COUNT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STAR-LITE -LM, MODEL SL8809
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sentinel Cerebral Protection System
FDA 510(k)
FDA Class 2
·Cardiovascular
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 23, 2020
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 2, 2014
ANGIOSEAL
FDA Adverse Event
Injury
·ST JUDE MEDICAL·Product code MGB·October 10, 2012
FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·May 22, 2015
E1 44-36 STD +3 HMRL BRG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 30, 2020
E1 44-36 STD +3 HMRL BRG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 30, 2020
COMP RVS TRAY CO 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 30, 2020
E-POLY 49-36 STD HMRL BRNG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 30, 2020
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025