10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490906685·INSTRUMENT 8951802 STRD DISTCR 18 X 14MM
RESOLUTION 360 CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PKL·December 2, 2024
FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Resolution Clip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NOVOPEN 3 (INSULIN DELIVERY DEVICE) NA
FDA Adverse Event
Other
·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·November 10, 2009
TRANSVENE
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 9, 2013
BONNET MIDLINE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·January 6, 2011
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024