29 results · 37ms · Sources: EU EUDAMED, US FDA

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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