29 results
·
37ms
·
Sources: EU EUDAMED, US FDA
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
FDA 510(k)
FDA Class 2
·Cardiovascular
KALORE™
FDA UDI
Gc America Inc.·D0470036211·KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 uniti...
KALORE™
FDA UDI
Gc America Inc.·14548161291361·KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 uniti...
Zavation
FDA UDI
Zavation LLC·00842166121409·ALIF 0deg 36mm x 21mm
ZAVATION
FDA UDI
Zavation LLC·00842166157002·HA+ ALIF 0deg 36mmx21
GentleYAG LE 3MM Delivery System W/DCD
FDA UDI
Candela Corporation·00817495021638·Delivery System Assembly
Zavation
FDA UDI
Zavation LLC·00842166180451·ALIF Sizer 0eg 36mm x 21mm
ZAVATION
FDA UDI
Zavation LLC·00842166154780·WHITNEY 0deg 36mmx21mm
DARDIK CAROTID SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 11, 2013
PYRENEES CERVIAL PLATE
FDA Adverse Event
Injury
·K2M, INC.·Product code KWQ·February 23, 2011
PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·February 15, 2008
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 31, 2019
OXF UNI CMNTLS TIB SZ D RM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·August 31, 2021
OXF ANAT BRG RT MD SIZE 6 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·August 31, 2021
LIGHTSHEER EC
FDA Adverse Event
Injury
·RH USA, INC.·Product code GEX·August 28, 2012
DRILL 1.6X50MM 22MM STOP
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HBE·July 28, 2016
Q-SYTE CLOSED LUER ACCESS DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·November 13, 2020
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 8, 2022