9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INDEX ACETABULAT COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
FDA 510(k)
FDA Class 2
·Orthopedic
Ez3D-i/E3
FDA 510(k)
FDA Class 2
·Radiology
COMPRESSION FORCEPS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWN·March 16, 2020
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 8, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 6, 2011
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code NMJ·June 9, 2014
COMPRESSION FORCEPS
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HWN·April 7, 2016
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