8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REPROSIL
FDA 510(k)
FDA Class 2
·Dental
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00147811510·2G Narrow VS4
GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COMPUMEDICS NEUVO
FDA 510(k)
FDA Class 2
·Neurology
TRIATHLON PRIM TIB BASEPLATE - CEMENTED
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 30, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 10, 2012
PLMA DVD V11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·July 29, 2010
Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016