7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
K-SOL(TM)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALERKAN SPIROMETRY FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
FDA 510(k)
FDA Class 2
·General Hospital
VLOC 90 2/0 VL 9 V-30
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code GAM·June 27, 2014
M2A-MAGNUM MOD HD SZ 56MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·January 11, 2013
OPES ASPIRATING ABLATOR
FDA Adverse Event
Malfunction
·ARTHREX, INC·Product code GEI·October 27, 2010
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