8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SSV PHONATE(TM) SHILEY SPEAKING VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
DAVOL ELECTROSUGICAL PROBES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OSTEONICS HIP REVISION WEDGES
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·February 1, 2013
UNKNOWN DEPUY ELITE HEAD BALL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·December 30, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 21, 2014
PRESCRIPTIVE OXY PACK - CAPIOX
FDA Adverse Event
Injury
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·April 30, 2018
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020