9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIOLIPIN G EIA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704268522·
GLUCOCHEK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
2.0MM THREADED GUIDE WIRE 230MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code DQX·February 6, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 4, 2011
E-POLY 36MM +3 HIWALL LNR SZ23
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MAY·July 21, 2014
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020