8 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MINT Product Family
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XPECT FLU A & B
FDA 510(k)
FDA Class 2
·Microbiology
DEPUY PINNACLE ALTRX ACETABULAR LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD, INC.·Product code JOH·June 19, 2013
OASYS BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code KWP·October 7, 2008
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·August 5, 2011
KITTNER (BLUNT) DISSECTOR, 9/16 X 1/4"
FDA Adverse Event
Malfunction
·DEROYAL GUATEMALA·Product code GDI·November 10, 2014
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