22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROROOT MTA WHITE, PROROOT MTA GRAY
FDA 510(k)
FDA Class 2
·Dental
MAXIM VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304205574·
EASY TOUCH
FDA 510(k)
FDA Class 2
·General Hospital
ORTHODONTIC CERAMIC BRACKETS
FDA 510(k)
FDA Class 2
·Dental
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·June 23, 2014
AXIUM DETACHABLE COIL
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code HCG·May 26, 2010
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 25, 2014
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 21, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 5, 2014
UNKNOWN DEPUY ENDURANCE CEMENT
FDA Adverse Event
Injury
·9610921 DEPUY CMW·Product code LOD·June 3, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·May 26, 2011
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021
BD PHOENIX PMIC110
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·October 19, 2021
BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·August 23, 2021
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
BD PHOENIX PANEL PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 10, 2023
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025