11 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ACCORDION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809849295·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE-...
EXPLANT™
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311831·
JBC OPAQUE AND GLITTER
FDA 510(k)
FDA Class 2
·Dental
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 27, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 11, 2013
HUT EXT DR FINAL ASSY-REVERSE
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·March 1, 2011
ACCU-CHEK INFORM BASE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·May 21, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014