9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFELINE(R) PERSONAL RESPONSE SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540244568·BONE SCREWS, CROSS-FIT, SELF-TAPPING
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150706·K-WIRE - SINGLE TROCAR 1.0mm DIA x 75mm
Shani Darden LED light therapy mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LINOX S 65
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·December 7, 2012
PFC SIGMARP STB TB IN 5 12.5
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·December 1, 2010
AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC·Product code DRM·July 3, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015