9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERNVANTAGE VARNISH LC, MODEL 221001
FDA 510(k)
FDA Class 2
·Dental
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984341·anteriors; shade B3; mould R 86
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11 X 360MM X 12
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 6, 2012
CRITICAL CARE I.V. STAND STABILIZING BRACKET
FDA 510(k)
FDA Class 1
·General Hospital
APTT REAGENT
FDA 510(k)
FDA Class 2
·Hematology
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·February 10, 2011
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·August 6, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024