8 results
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18ms
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Sources: EU EUDAMED, US FDA
AROMAPATCH
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984345·anteriors; shade B3; mould 90
ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
MODEL ESP-200 MAMMOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
NC QUANTUM APEX?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·August 6, 2014
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JLB·February 10, 2011
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