7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NORTHGATE FLOW ASSIST TUBING FOR UROLOGY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mammo Workstation
FDA 510(k)
FDA Class 2
·Radiology
ACCUHEART ELECTRODE BELT
FDA 510(k)
FDA Class 2
·Cardiovascular
HUMAPEN ERGO TEAL/OPAQUE
FDA Adverse Event
Malfunction
·ELI LILLY AND COMPANY·Product code NSC·February 5, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 1, 2011
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 18, 2014
VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
FDA Enforcement
Class II
·Ongoing·Visionsense, Ltd.·November 30, 2022