18 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OPD-STATION SOFTWARE
FDA 510(k)
FDA Class 1
·Ophthalmic
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902994203·CASE 7050336 CDHL 5.5 DGNRTV INS TRAY
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
FDA 510(k)
FDA Class 2
·Immunology
ADVANTAGE WINDOWS CT/PET FUSION
FDA 510(k)
FDA Class 2
·Radiology
AEQ REV II GLENOID BASEPLATE DIA 25MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code PHX·July 1, 2025
AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 13, 2025
AEQ REV GLENOID BASEPLATE 29MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 6, 2025
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 8, 2013
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·April 12, 2011
E-CENTRIX ULNAR HEAD
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KXE·May 23, 2008
AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 25, 2024
D.4,5MM COMPRESSION SCREW L.32MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 7, 2025
D.4,5MM COMPRESSION SCREW L.23MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 7, 2025
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2019
AEQ REV GLENOID BASEPLATE 29MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·May 21, 2024
6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018
6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018
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