21 results
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35ms
·
Sources: EU EUDAMED, US FDA
ENZYME IMMUNOASSAY FOR DETECTION HORM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TK2 ™SHORT BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868052996·
TK2 ™STANDARD BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868052910·
TK2 ™STANDARD BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868052903·
TK2 ™SHORT BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868053016·
TK2 ™STANDARD BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868052941·
TK2 ™STANDARD BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868052972·
TK2 ™STANDARD BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868052927·
TK2 ™STANDARD BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868052989·
TK2 ™SHORT BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868053009·
TK2 ™STANDARD BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868052958·
TK2 ™STANDARD BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868052965·
TK2 ™STANDARD BARREL
FDA UDI
Biomet Orthopedics, LLC·00887868052934·
CONTACT DETACH
FDA 510(k)
FDA Class 2
·General Hospital
ORTHO AUTOMATED CELL COUNTER
FDA 510(k)
FDA Class 2
·Hematology
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·May 30, 2014
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 22, 2012
PYXIS ANESTHESIA SYSTEM (PAS)
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BRY·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