11 results
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25ms
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Sources: EU EUDAMED, US FDA
SALTER LABS DISPOSABLE NIPPLE AND NUT
FDA 510(k)
FDA Class 1
·Anesthesiology
VARIAX
FDA UDI
Stryker GmbH·04546540540713·Profyle Hand Implant Module S.L.
Malibu
FDA UDI
Seaspine Orthopedics Corporation·10889981080976·Tap 5.5mm (for 6.0mm Screw)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450241332·
ERIS LAYERING MATERIALS
FDA 510(k)
FDA Class 2
·Dental
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 11, 2013
MAXIMO II CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·December 2, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 3, 2014
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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
PM 1260 ASSURITY + 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