52 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
FDA 510(k)
FDA Class 2
·Dental
Endo GIA
FDA UDI
Covidien LP·10884523002997·Universal Loading Unit
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120304251·Diamond, cylinder rounded edge, medium grit
IDRIVE ULTRA POWERED HANDLE 1
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·February 19, 2014
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00811801033469·Extra Large ALIF Cobb - 25 mm
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0604250·Tray, Base, 4.25"
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDO GIA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·May 31, 2024
ENDO GIA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·May 31, 2024
ENDO GIA ULTRA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·July 19, 2023
ENDO GIA ULTRA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·February 22, 2024
UNKNOWN ENDO GIA INSTRUMENT
FDA Adverse Event
Malfunction
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·January 20, 2025
ENDO GIA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·December 9, 2024
ENDO GIA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·April 24, 2024
ENDO GIA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·April 24, 2024
ENDO GIA ULTRA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·April 15, 2024
ENDO GIA ULTRA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·August 30, 2024
ENDO GIA II 45-2.5 DLU
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GCJ·November 15, 2004
ENDO GIA ULTRA
FDA Adverse Event
Malfunction
·COVIDIEN·Product code GDW·December 5, 2025