8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHETIC ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
FDA 510(k)
FDA Class 2
·Neurology
LCP SUP-CLAVIC-PL 3.5 7HO LE L110 TAN
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HRS·July 25, 2013
ADVIA 2400
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·May 24, 2013
PROMOTE PLUS CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 30, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019