10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOCHECK FERRITIN ELISA MODEL BC-1025
FDA 510(k)
FDA Class 2
·Immunology
KODAK X-OMAT RP FILM
FDA 510(k)
FDA Class 1
·Radiology
Psychemedics Microplate EIA for Cotinine in Hair
FDA 510(k)
FDA Class 1
·Clinical Toxicology
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025
SYNCHROMED EL
FDA Adverse Event
Death
·RICE CREEK MFG·Product code LKK·March 7, 2013
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·August 8, 2014
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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