86 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
FDA 510(k)
FDA Class 2
·Neurology
MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
I-MAX TOUCH 3D
FDA 510(k)
FDA Class 2
·Radiology
AS 50 INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·November 17, 2008
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·August 15, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·December 9, 2024
BD MINIDRAW¿ FINGER SLEEVE, LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·December 9, 2024
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·November 27, 2024
BD MINIDRAW¿ FINGER SLEEVE, SMALL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·November 27, 2024
BD MINIDRAW¿ FINGER SLEEVE, LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·November 27, 2024
BD MINIDRAW¿ FINGER SLEEVE, SMALL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·November 27, 2024
BD MINIDRAW¿ FINGER SLEEVE, LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·April 9, 2025
BD MINIDRAW¿ FINGER SLEEVE, LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·April 9, 2025
BD MINIDRAW¿ FINGER SLEEVE, LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·April 9, 2025
BD MINIDRAW¿ FINGER SLEEVE, LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·April 8, 2025
BD MINIDRAW¿ FINGER SLEEVE, LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·April 9, 2025
BD MINIDRAW¿ FINGER SLEEVE, MEDIUM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·April 4, 2025