8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MANAN SUPER-CORE BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Endoscopy Valve Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Diamondback 360 Peripheral Orbital Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCESSORIES
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·June 9, 2014
MINICAP
FDA Adverse Event
Death
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·February 8, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
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