8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REAL TIME X-RAY IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756393997·BASIC SETUP PACK
BETA I & BETA II
FDA 510(k)
FDA Class 2
·Radiology
TPO IGG ANTIBODY EIA TEST
FDA 510(k)
FDA Class 2
·Immunology
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·January 11, 2013
PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-HOLES
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·November 24, 2010
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024