12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUCTION LIPOPLASTY ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AGXO
FDA UDI
Oticon A/S·05707131258953·H150, MINIRITE 312 WL TC AGXO
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102558·KOCH-NAGAHARA KARATE CHOPPER, LEFT D-E
GEODESIC EEG MOBILE 100 (GEM 100)
FDA 510(k)
FDA Class 2
·Neurology
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·December 28, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·October 1, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·June 13, 2011
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·August 17, 2022
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021