8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Snorer's Friend
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
KEY SURGICAL, INC.·10849771049798·Steinmann Pins, Single trocar, round end, 0.188...
XTRACT CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BD DIRECTIGEN EZ FLU A+B ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 21, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
CELL-DYN 3700 SL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·September 17, 2008
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021