8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fingertip Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
ALICIA MENSTRUAL CUP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 14, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 30, 2011
8010042-2008-00090
FDA Adverse Event
Malfunction
·Product code CBK·July 8, 2008
AMISTEM H, HA COATED STEM SIZE 5 STD
FDA Adverse Event
Death
·MEDACTA INTERNATIONAL SA·Product code LZO·September 20, 2017
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