9 results · 18ms · Sources: EU EUDAMED, US FDA

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SKIN TECH. ISOTEX 86L

FDA 510(k)
FDA Class 1 ·General Hospital

CoRoent

FDA UDI
Nuvasive, Inc.·00887517375131·CoRoent Small Contoured, 9L Open

RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RAPID PROGRAMMER

FDA 510(k)
FDA Class 2 ·Neurology

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 30, 2014

ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·November 20, 2012

ROTOSNARE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FDI·September 22, 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

Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021