9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F
FDA 510(k)
FDA Class 2
·Immunology
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984347·anteriors; shade B3; mould 92
Sklar
FDA UDI
SKLAR CORPORATION·10649111450235·BROCK MICRO FCP W/PLATFORM 7 IN
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
FDA 510(k)
FDA Class 2
·Neurology
KALTOCARB WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
ATLAS II HF CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·February 28, 2013
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JLB·February 10, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·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