13 results · 26ms · Sources: EU EUDAMED, US FDA

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TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

TruLock

FDA UDI
Rmo, Inc.·00885797644923·TRULOCK Primer Activated Adhesive Kit (4ea Syri...

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690196358·AK3 PS-C Insert Trials - Size 1-5 Pan

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036209216·

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690195054·AK3 PS-C Insert Trials - Size 1-5 Pan Insert

ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 9, 2018

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Injury ·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012

UNIFY CRT-D

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 2, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 15, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·May 5, 2011

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