8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
WELLPREP 2000 SAMPLE PROCESSOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MOUTH GAGS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
AUGMENT AND SCREW, PSA TYPE
FDA 510(k)
FDA Class 2
·Orthopedic
ENDO CATCH GOLD
FDA Adverse Event
Injury
·DAVIS & GECK CARIBE LTD·Product code GCI·June 11, 2018
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
HUDSON MICRO MIST NEBULIZER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAF·January 16, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015