8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
KOLLMANN URETHRAL DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Heyman Packing Applicator Set (GM11004580)
FDA 510(k)
FDA Class 2
·Radiology
RAVEN PROTEST - STEAM
FDA 510(k)
FDA Class 2
·General Hospital
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 30, 2014
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 21, 2012
REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·September 7, 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
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