11 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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FOUNDATION 9MM FORGED CEMENTED STEM
FDA 510(k)
FDA Class 2
·Orthopedic
P.F.C. SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295240419·P.F.C. SIGMA DISTAL AUGMENTATION TRIAL SZ 4 12mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471149854·K-WIRE - DOUBLE TROCAR FULLY THREADED 1.8mm DIA...
100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2
FDA 510(k)
FDA Class 1
·Pathology
MARK IV FLOATATION THERAPY BED
FDA 510(k)
FDA Class 2
·Physical Medicine
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·February 14, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·January 14, 2011
HOLDING SLEEVE-LONG FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·July 28, 2014
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 6, 2016