10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KERATEC WOUND DRESSINGS
FDA 510(k)
FDA Unclassified
·Unknown
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608501·BERCHTOLD 2.25" SOFTCARE PLUS
APOLLO, MODEL 1124525
FDA 510(k)
FDA Class 2
·Dental
2010 PLUS HOLTER FOR WINDOWS
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INTEGRA PRECISIONGLIDE
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·December 14, 2025
3.5MM TI LCP® RECONSTRUCTION PLATE 8 HOLES/112MM
FDA Adverse Event
Injury
·SYNTHES RARON·Product code KTT·July 21, 2017
CORAIL2 LAT COXA VARA SIZE 9
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE·Product code KWA·April 26, 2013
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·May 8, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·July 23, 2008
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018