13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Seaman Pro/Seaman
FDA 510(k)
FDA Class 2
·Hematology
Ormco
FDA UDI
ORMCO CORPORATION·00889989074840·TUBE RECT SOFT 22X28X4.5MM 2-1011
ELITE
FDA UDI
DEPUY INTERNATIONAL LTD·10603295128601·ELITE IMPL TR HD 28MM +3
ELITE
FDA UDI
DEPUY INTERNATIONAL LTD·10603295128588·ELITE IMPL TR HD 28MM -3
ELITE
FDA UDI
DEPUY INTERNATIONAL LTD·10603295128618·ELITE IMPL TR HD 28MM +6
ELITE
FDA UDI
DEPUY INTERNATIONAL LTD·10603295128595·ELITE IMPL TR HD 28MM +0
Hydroven 12, Hydroven 12 Garments
FDA 510(k)
FDA Class 2
·Cardiovascular
SMIT SLEEVE
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
aap Implantate AG·04042409194795·Angle Stable Cortical Screw 2.5, self-tapping, ...
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Death
·W. L. GORE & ASSOCIATES·Product code MIH·December 4, 2008
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 16, 2011
INFINITY DENTAL IMPLANT SYSTEM
FDA Adverse Event
Injury
·ACE SURGICAL SUPPLY CO.·Product code DZE·July 25, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024