7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
REPLACE CYLINDRICAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE
FDA 510(k)
FDA Class 2
·Anesthesiology
PRECIMAT GLYCEROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FOLEY CATHETER, 2W SOFT VALVE STD 5/10CC CH16
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code KOD·February 22, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 7, 2011
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 5, 2014
Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017