9 results
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27ms
·
Sources: EU EUDAMED, US FDA
BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL
FDA 510(k)
FDA Class 1
·Physical Medicine
WIRE TWISTERS
FDA 510(k)CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE
FDA 510(k)
FDA Unclassified
·Unknown
G7 HI-WALL E1 LINER 36MM G
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·January 20, 2021
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 6, 2014
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·November 27, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NKB·September 3, 2010
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
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