9 results
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26ms
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Sources: EU EUDAMED, US FDA
ORTHO MICROWELL READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR
FDA 510(k)
FDA Class 2
·Orthopedic
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W
FDA 510(k)
FDA Class 2
·Radiology
NANOTITE TM TAPERED CERTAIN® IMPLANT 4 X 10MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·December 20, 2025
ARCHITECT TSH
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code JLW·May 30, 2014
3M COMPLY STERIGAGE
FDA Adverse Event
Malfunction
·3M HEALTH CARE BUSINESS·Product code JOJ·October 12, 2012
LEXOS VR-T
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·September 17, 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
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