12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pocket Ultrasound System (C10)
FDA 510(k)
FDA Class 2
·Radiology
TRIAL HEAD DEF.STEM 12/14 D.32 +3,5
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489313547·
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021680·INTRG WHISP MBT CUS 0T +3A 022 LL
LOCKING SCREW, FULLY THREADED 5X45 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009
EBI OMEGA21 SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RENOVIS BIPOLAR HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN ORTHOSIS
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code MNI·January 6, 2017
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 26, 2011
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·July 17, 2013
PAXGENE BLOOD CCFDNA TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 20, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025