14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776305369·Lempert Rongeur 7.5" CVD 3x9mm SA
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780142706·Integra® Jarit® LEMPERT RONGEUR
RM52260149 DS10014928 BI MENTUM RK PE LINER 28 49
FDA Adverse Event
Injury
·S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION·Product code MEH·January 24, 2025
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
FDA 510(k)
FDA Class 2
·Neurology
DRIP ALERT
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
Widex
FDA UDI
Widex A/S·05706069914870·WIDEX MOMENT MRB2D (Deep Blue ) 330, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069827668·WIDEX EVOKE EBB3D (Deep Blue ) 330, Telecoil, R...
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 31, 2011
*
FDA Adverse Event
Other
·*·Product code KBZ·July 25, 2008
PULSE GEN MODEL 102
FDA Adverse Event
Death
·CYBERONICS INC·Product code LYJ·July 16, 2013
LAPIPLASTY SYSTEM S4A
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025