10 results
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33ms
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Sources: EU EUDAMED, US FDA
URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746048111·WIRE SS GOLD TONE LOWER 017 X 022 BONWILL HAWLE...
NOSITE UV INTERIM SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
Saige-Dx
FDA 510(k)
FDA Class 2
·Radiology
FORCETRIAD
FDA Adverse Event
Malfunction
·COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON OF TYCO HEALTHCARE·Product code GEI·August 29, 2014
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 6, 2014
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·December 3, 2012
TERUMO TCM II COOLING AND HEATING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DWC·September 3, 2010
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024