7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
IL TEST CALCIUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INMODE WMBODY DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VUEPOINT OCT SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code KWP·April 8, 2014
CORTSCR Ø1.5 SELF-TAP L11 TAN
FDA Adverse Event
Malfunction
·SYNTHES·Product code DZL·January 28, 2013
ASR ACETABULAR CUPS 44
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 15, 2010
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024