7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
PRESSURE INFUSER
FDA 510(k)
FDA Class 1
·General Hospital
HANDHELD GAMMA FINDER (HGF)
FDA 510(k)
FDA Class 1
·Radiology
RANDOX COCAINE METABOLITE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·January 14, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·November 23, 2010
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 3, 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