12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAVIPRO SHOULDER SOFTWARE MODULE
FDA 510(k)
FDA Class 2
·Neurology
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490484350·PYRAMESH A TRAY
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·May 14, 2025
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·May 14, 2025
DEPUE
FDA Adverse Event
Injury
·DEPUE·Product code HRS·May 22, 1997
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
FDA 510(k)
FDA Class 2
·Hematology
MERIDIAN-PORTABLE
FDA 510(k)
FDA Class 2
·Neurology
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·April 10, 2013
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
ECC.O SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL
FDA Adverse Event
SORIN GROUP ITALIA·Product code KFM·February 29, 2016
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