8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
SHARPE ENDOLIGATURE CARRIER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FORTRESS MODEL 760-V 4 WHEEL POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
SURGICAL FACE MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 15, 2013
UNKNOWN TSL
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·November 29, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 7, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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