11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pro-Tx Endorectal Balloon (PROT-25)
FDA 510(k)
FDA Class 2
·Radiology
V-Strap Wrist Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357232499·
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 15, 2022
DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 29, 2014
UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 12, 2011
ISOFLEX S
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·July 12, 2013
COPAN WASP/COLIBRI
FDA Adverse Event
Other
·COPAN WASP·Product code QQV·July 25, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025