13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Frontier Series Power Wheelchairs
FDA 510(k)
FDA Class 2
·Physical Medicine
MaXcess
FDA UDI
Nuvasive, Inc.·00887517189172·MaXcess Access Blade, 90mm Center
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514803·
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981298333·Iliac Tap, Cannulated, Navigated, 9.0mm
LEVEEN SUPERSLIM NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOPRO 67D OPERATING ROOM CAMERA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
LEVEEN¿ COACCESS¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code GEI·September 7, 2017
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 16, 2011
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·September 1, 2014
8.0CM MEDIUM ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 9, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021