7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORS-100
FDA 510(k)
FDA Class 1
·Clinical Chemistry
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123830·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 200mm
DALI SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
KOLO Evolution XHD Series Ultrasound Diagnostic System
FDA 510(k)
FDA Class 2
·Radiology
CAPSURE SENSE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code PAH·January 10, 2013
JRNY BCS II
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·July 9, 2014