11 results
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20ms
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Sources: EU EUDAMED, US FDA
SUCTION CATHETER W/STERILE WATER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788225100·Cervical Trial 7x16x13, 12 deg Lordotic
TRIHA+
FDA UDI
TEKNIMED·03760177041493·
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113706·PS-C Insert, Size 5 x 10mm
ICRCO 3600M
FDA 510(k)
FDA Class 2
·Radiology
FONIX, MODEL 7000
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
OPTICROSS?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·May 21, 2014
NEXGEN CR-FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·November 2, 2012
DEPUY ASR XL FEM IMP SZ 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·August 27, 2010
BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018
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