7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BOUNDARY SINGLE-USE OR GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Joylux Intimacy Gel (PG3100)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DUREX PLAY TINGLING LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 13, 2014
LAG SCREWS, REGULAR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HWC·November 21, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2015
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021