18 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
FDA 510(k)
FDA Class 2
·Dental
Phasix
FDA UDI
Davol Inc.·00801741161292·Phasix ST Mesh with Echo 2 Positioning System, ...
EMERALD SYRINGE 5ML 24X1 AN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 4, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
ZAVATION CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
BD SYRINGE 1ML ST BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 28, 2024
BD SYRINGE 1ML ST BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 26, 2024
COBAS 8000 C 702 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 22, 2017
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS LLC (PR)·Product code NIQ·October 24, 2008
ECHELON*FLEX60 COMPACT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 16, 2011
TRANSVENOUS
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
1823260-2017-02030
FDA Adverse Event
Malfunction
·September 21, 2017
BD SYRINGE 1ML ST BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·February 14, 2024
BD SYRINGE 1ML ST BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·February 13, 2024
GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HSB·October 24, 2024
COBAS 8000 C 702 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 19, 2017
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023