15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEONE SPA
FDA UDI
LEONE SPA·08033707017721·CALIBRA 1ST MOLAR BANDS n.LR 21
EZ-Fill Bi-Directional Spiral
FDA UDI
ESSENTIAL DENTAL SYSTEMS, INC.·00766054000280·EZ-Fill Bi-Directional Spiral 21mm Nickel Titanium
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613154020546·Cruciate Retaining Tibial Insert
BINAXNOW COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·November 1, 2021
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·November 12, 2021
EVERON CENTRAL DISPLAY STATION (CDS)
FDA 510(k)
FDA Class 2
·Cardiovascular
COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS
FDA 510(k)
FDA Class 2
·Cardiovascular
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·June 10, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 17, 2014
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 5, 2011
ROOT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·September 20, 2018
AEQUALIS STEM FOR FRACTURE D.6.5 HA-COATED
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 5, 2026