9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
FDA 510(k)
FDA Class 2
·Immunology
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127024184·Quick Connect Ratcheting Handle, D25-132-R-T30-ZIH
G-SCAN CERVICAL SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
MaxiGen
FDA 510(k)
FDA Class 2
·Orthopedic
SEE H10
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 17, 2020
CAPSURE EPI
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code DTB·February 9, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 7, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 23, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024