8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROCHE CRP T CONTROL N
FDA 510(k)
FDA Class 2
·Immunology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982087·posteriors; shade C2; size S; lower jaw
EYEFEEL OPHTHALMIC WARMER
FDA 510(k)
FDA Class 1
·Physical Medicine
DynaMesh-POSTERIOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMFORT COOL THUMB CMC RESTRICTION SPLINT
FDA Adverse Event
Injury
·NORTH CCOAST MEDICAL, INC.·Product code ILH·October 26, 2017
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2013
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·August 5, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024