10 results · 21ms · Sources: EU EUDAMED, US FDA

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ASCA-CHEK

FDA 510(k)
FDA Class 2 ·Immunology

PF4 IGG

FDA Adverse Event
Malfunction ·IMMUCOR GTI DIAGNOSTICS·Product code GWG·January 16, 2015

M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

COCR FEMORAL HEAD

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·February 23, 2018

ENRHYTHM

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·April 22, 2013

ASR ACETABULAR CUPS 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011

INFINIA HAWKEYE4

FDA Adverse Event
Malfunction ·GEMS ISRAEL, FUNCTIONAL IMAGING·Product code KPS·July 9, 2008

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

FDA Enforcement
Class II ·Terminated·Exactech, Inc.·October 7, 2020

Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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