8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROTECTA COAT SPONGES
FDA 510(k)
FDA Class 2
·Radiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209133802·
IFL PROFESSIONAL SYSTEM, MODEL C100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)
FDA 510(k)
FDA Class 2
·Cardiovascular
PLATE ANCHORAGE LAPIDUS / CROSS PLATE STEP 0MM - RIGHT
FDA Adverse Event
Malfunction
·STRYKER TRAUMA SELZACH·Product code HRS·May 30, 2014
RECEPTAL CANISTER 1000 ML CE
FDA Adverse Event
Malfunction
·AMSINO MEDICAL CO., LTD·Product code GCX·November 13, 2012
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 12, 2015
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018