7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
FDA 510(k)
FDA Class 2
·Cardiovascular
VivaScope System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL EV600R
FDA Adverse Event
Injury
·NEW STAR LASERS, INC.·Product code GEX·March 4, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 12, 2007
TRANSVENE SVC/CS
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWS·October 31, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024