14 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VISUALASE THERMAL THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Harvard Temp C&B A3
FDA UDI
Harvard Dental International GmbH·EHAR70816561·Temporary crown and bridge material 10:1
AVALIGN
FDA Adverse Event
Malfunction
·AVALIGN GERMAN SPECIALTY INSTRUMENTS·Product code HAE·June 17, 2019
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
FDA 510(k)
FDA Class 2
·Radiology
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 22, 2023
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·NULL·Product code FPA·February 4, 2022
TOTAL ASR FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·April 29, 2013
PALMAZ GENESIS OPTA PRO
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code FGE·May 9, 2011
PUMP MMT-722LNAB PRDGM INS BL EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·July 23, 2008
Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018