7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
HYDROPHILIC COATED GUIDEWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THROMBO-CALIBRATOR KIT
FDA 510(k)
FDA Class 2
·Hematology
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 2, 2014
PERIGEE SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 16, 2013
INSYNC SENTRY
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·December 14, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024