10 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VACU-MED BLOOD COLLECTION NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2017
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
T.I.M.S., VERSION 2.00
FDA 510(k)
FDA Class 2
·Radiology
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 22, 2013
UNKNOWN
FDA Adverse Event
Injury
·LUMENIS, INC.·Product code GEX·April 28, 2011
ONYX VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·July 10, 2008
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018