8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
T3 CLASP-BEAD EIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127628·AK3 PS Insert Trial Size 6, 20mm
PULPDENT FLUORIDE VARNISH
FDA 510(k)
FDA Class 2
·Dental
OptoMonitor 3
FDA 510(k)
FDA Class 2
·Cardiovascular
SUMMIT POR TAPER SZ5 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.-1818910·Product code LPH·June 25, 2014
LARGE NEEDLE DRIVER
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·January 2, 2013
POLYSORB 2/0 30 U/D C-23 211S
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GAM·November 3, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020