118 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HandX Monopolar Scissors
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bernafon
FDA UDI
Sbo Hearing A/S·05714464031436·AO7 MNR T MAC ALIGO 7
Bfix Orthopedic External Fixator Systems
FDA 510(k)
FDA Class 2
·Orthopedic
PicoLO Nd: YAG Picosecond Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2024
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·August 12, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013
PUMP,INSULIN,511 NA CLEAR
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·February 2, 2008
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·March 5, 2025
BD MINIDRAW¿ FINGER SLEEVE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·February 27, 2025
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·December 9, 2024
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·May 15, 2024
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·August 6, 2024
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 29, 2025
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 29, 2025
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 29, 2025
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 29, 2025
BD MINIDRAW¿ FINGER SLEEVE, LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·December 9, 2024
BD MINIDRAW¿ FINGER SLEEVE, MEDIUM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·December 4, 2024