8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
KINETIC TECHNOLOGY PRECISION ADJUSTOR MOD. SHLCP-5
FDA 510(k)
FDA Unclassified
·Unknown
SIGNAL DISTRIBUTION NETWORK #78581A
FDA 510(k)
FDA Class 2
·Cardiovascular
troCarWash System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PUMP IN STYLE ADVANCED
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·November 12, 2010
SPECTRUM INFUISON PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·January 14, 2014
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·December 28, 2012
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020
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