7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SONASSAGE
FDA 510(k)
FDA Class 1
·Physical Medicine
MCPULSE
FDA 510(k)
FDA Class 2
·Cardiovascular
ACHILLES
FDA 510(k)
FDA Class 2
·Radiology
SCHANZ SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HWC·January 18, 2013
UNK
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code GZB·November 9, 2010
TENDRIL ST
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·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