9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
QUIDEL TOTAL IGE POSITIVE CONTROL SERUM
FDA 510(k)
FDA Class 2
·Immunology
Florida Utilities Linemans - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588051628·Florida Utilities Linemans - 18 Metal
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221113023·3M™ Victory Series™ Second Molar Bands, 905-162...
STERIMATIC(TM) SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
DGH A-SAN PROBE HOLDER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·November 22, 2010
ETS FLEX ARTICNG LNR CUTR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 1, 2014
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025