7 results
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53ms
·
Sources: EU EUDAMED, US FDA
ASPIRATION & IRRIGATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
4D INTEGRATED TREATMENT CONSOLE
FDA 510(k)
FDA Class 2
·Radiology
CANDELA CBEAM PULSE DYE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 27, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 26, 2012
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 13, 2010
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