8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Premium Surgiclip¿; Endo Clip¿; AcuClip¿
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PILOT TUBE REPAIR KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
VIZION + DR
FDA 510(k)
FDA Class 2
·Radiology
Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 3, 2013
UNKNOWN DEPUY ACETABULAR SHELL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·August 28, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 29, 2011
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·May 16, 2018