9 results · 29ms · Sources: EU EUDAMED, US FDA

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TRYPTICASE SOY BROTH

FDA 510(k)
FDA Class 1 ·Microbiology

TECNOL TELEMETRY UNIT POUCH

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)

FDA 510(k)
FDA Class 2 ·Cardiovascular

M2A-MAGNUM PF CUP 46ODX40ID

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 2, 2014

FENESTRATED BIPOLAR FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 21, 2012

DUROM US ACETABULAR COMPONENT

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code KWA·September 16, 2010

COREVALVE TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 7, 2019

UNK - CONSTRUCTS: PFNA

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HSB·March 2, 2021

Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018