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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

WESTERMAN-JENSEN BIOPSY NEEDLE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209131921·

EASYSTIM TN28_OTC

FDA 510(k)
FDA Class 2 ·Neurology

MODIFICATION TO GEO STRUCTURE

FDA 510(k)
FDA Class 2 ·Orthopedic

ADMIRAL XTREME PTA BALLOON CATHETER

FDA Adverse Event
Injury ·INVATEC SPA·Product code LIT·May 30, 2014

CAPIOX FX OXYGENATOR W/O RESERVOIR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 13, 2012

ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE KIT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·September 21, 2010

Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

FDA Enforcement
Class II ·Terminated·STERILMED, INC.·December 16, 2015

Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018