8 results
·
16ms
·
Sources: EU EUDAMED, US FDA
CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Archon
FDA UDI
Nuvasive, Inc.·00887517251398·Archon Plate, 88mm 4-Level Wide
Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 27, 2016
DIAZYME LP(A) ASSAY
FDA 510(k)
FDA Class 2
·Immunology
Reprocessed Response Diagnostic Electrophysiology Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2014
PUMP MMT-554CAH PRDGM INS PK
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·October 21, 2010
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 20, 2012