11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vitra 2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Oticon A/S·05707131340139·SIYA 2, KIT 312 NFM PB R C001
DROPSAFE 25G NEEDLE
FDA Adverse Event
Malfunction
·HTL-STREFA, INC.·Product code FMI·September 1, 2022
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MINI MAXLOCK EXTREME PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·December 29, 2021
BD KIESTRA IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013
CELL-DYN 3700 SL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 4, 2011
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020