10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP
FDA 510(k)
FDA Class 2
·Orthopedic
Malibu
FDA UDI
Seaspine Orthopedics Corporation·10889981080877·Pistol Guide
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471144330·PASSING PIN - DRILL TIP 2.4mm DIA x 385mm
Halyard ONE-STEP* Sterilization Wrap
FDA 510(k)
FDA Class 2
·General Hospital
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HS III PROXIMAL SEAL SYS 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·May 13, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 11, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 2, 2010
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