9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CONTROL SET, EMIT METHOTREXATE
FDA 510(k)
FDA Class 1
·Clinical Toxicology
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
Affixus Natural Nail System Humeral Nail
FDA 510(k)
FDA Class 2
·Orthopedic
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 2, 2022
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·August 26, 2019
UNIFY CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·April 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·June 20, 2007
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 11, 2012
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026