13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 350G GAS CONSERVER
FDA 510(k)
FDA Class 2
·Anesthesiology
AMARA GEL
FDA UDI
Respironics, Inc.·00606959021167·AMARA GEL MASK WITH RS FRAME AND HEADGEAR INTL,...
Inverted Reamer-AO ø 44
FDA UDI
Spierings Orthopaedics B.V.·08720256027201·
RELION INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·December 21, 2020
BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 12, 2026
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·November 17, 2009
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
3.5MM 90-S SERFAS ENERGY SUCTION PROBE
FDA Adverse Event
Injury
·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·May 2, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·September 15, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 16, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012