7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
VABRA ABORTION UNIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HU II / HS II FIXTURE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Infrared Ear Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTH CORPORATION·Product code FRN·January 7, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 10, 2012
ACCU-CHEK MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·September 14, 2007
Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016