18 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SAS STREPALERT
FDA 510(k)
FDA Class 1
·Microbiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450512517·
STEVE MADDEN
FDA UDI
FGX INTERNATIONAL INC.·00193033483015·
INSET
FDA Adverse Event
Injury
·UNOMEDICAL UM-D·Product code FPA·February 9, 2026
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 22, 2026
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 22, 2026
INSET
FDA Adverse Event
Injury
·UNOMEDICAL UM-D·Product code FPA·February 9, 2026
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 22, 2026
INSET
FDA Adverse Event
Injury
·UNOMEDICAL UM-D·Product code FPA·February 9, 2026
V-40/C-TAPER ADAPTER SLEEVE
FDA 510(k)
FDA Class 2
·Orthopedic
IL TEST FREE PROTEIN S
FDA 510(k)
FDA Class 2
·Hematology
ASR ACETABULAR IMPLANT 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·March 10, 2011
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·August 8, 2022
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014