10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stern IC 4.3 mm Drill
FDA UDI
STERNGOLD DENTAL LLC·00841549115141·A metal device used in dental surgery to create...
DISTRACTION, INTERNAL
FDA UDI
KLS-Martin L.P.·00888118095084·DIST, LEFORT 1, ZURICH TELE, LEFT, 2.0-2.3 MM S...
DISTRACTION, INTERNAL
FDA UDI
KLS-Martin L.P.·00888118095091·DIST, LEFORT 1, ZURICH TELE, RIGHT, 2.0-2.3 MM ...
FORTRESS COMMUTER FT (FOLDING TRANSPORT)
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 23, 2010
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2014
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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