12 results
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27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HandPICO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
X-CORE
FDA UDI
Nuvasive, Inc.·00887517434265·X-CORE 2 Ti Core, Ø22x28-41mm
Suture Shuttle Left - Green
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215164881·
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127029905·Bipolar Head Assembly, Size 41mm
FlexPointer 1.5 Single Use, FlexTube 3 Single Use
FDA 510(k)
FDA Class 2
·Neurology
IALUSET HYDROCOLLOID
FDA 510(k)
FDA Unclassified
·Unknown
BARRIGEL INJECTABLE GEL
FDA Adverse Event
Malfunction
·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·November 3, 2014
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·August 12, 2011
UNIFY ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025