10 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HUANQIU HEATING LAMP
FDA 510(k)
FDA Class 2
·Physical Medicine
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809849363·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE EXTRA LA...
BIOTRACE, MODEL 1730
FDA 510(k)
FDA Class 2
·Neurology
SAFEPRO SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
LONG SMALL HEXAGONAL SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code HXX·February 13, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 11, 2013
INJECTOR, OPTIVANTAGE DH W/RFID
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code IZQ·March 1, 2011
PRECISION XTRA / OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·May 20, 2008
SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025
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