10 results
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34ms
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Sources: EU EUDAMED, US FDA
ALPHA URINE SAMPLE
FDA 510(k)
FDA Class 1
·Clinical Toxicology
VERTEX® Reconstruction System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902293559·BONE SCREW 6900626 4.0MMX26MM CORT TI
Lower ROC Kit for Herbst
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199006260·
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420117823·
SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENDOSERTER
FDA 510(k)
FDA Class 1
·Ophthalmic
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·June 27, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 7, 2013
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 8, 2010
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017