8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
VARIAX
FDA UDI
Stryker GmbH·04546540605467·Guide for Half-pins - Distractor II Diam. 3,4mm
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
XLD 110V L.A. REF
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 27, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·January 28, 2013
PUMP MMT-515LNAL PRDGM INS V2.1 CL EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·December 8, 2010
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