16 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DLP Silicone Coronary Artery Ostial Cannulae
FDA 510(k)
FDA Class 2
·Cardiovascular
ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SURESUBTRACTION ORTHO
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·October 15, 2014
CORDLESS DRIVER 3
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·July 19, 2011
MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·July 17, 2013
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 4, 2025
ULTRASAFE X50 PNG CLEAR PFE PUURS
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·October 15, 2020
COMP RVS TRAY CO 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·March 14, 2019
COMP RVSR SHLDR GLNSP +3 41MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·March 14, 2019
ORTHOPEDIC SALVAGE SYSTEM SMOOTH STRAIGHT IM STEM 11MM X 150MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 29, 2025
HERBERT PM COMPR RVS HA BP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·March 14, 2019
VERSA-DIAL/COMP TI STD TAPER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·March 14, 2019
COMP PRIMARY STEM 8MM STD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·March 14, 2019
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018