10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WHITESIDE ORTHOLOC MODULAR-C TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Precept
FDA UDI
Nuvasive, Inc.·00887517387134·PRECEPT Screw Shank, 6.0x45mm Modular
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809916497216·Long-arm Multi-Axial Fenestrated Screw, Ø6.0 x ...
Secure IM Nail
FDA UDI
A.M. SURGICAL, INC.·00857915007064·One 45mm x 1.6mm IM Nail
MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)
FDA 510(k)
FDA Class 3
·Cardiovascular
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STYLE 168 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN·Product code FWM·June 12, 2014
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010
UNKNOWN ENDO GIA SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SUR·Product code GDW·December 27, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024