8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Spinal Elements Navigated Instruments
FDA 510(k)
FDA Class 2
·Neurology
ULTRASONIC SURGICAL UNIT
FDA 510(k)
FDA Class 2
·Dental
SYNAPSE OBLIQUUS MIP/MPR/FUSION
FDA 510(k)
FDA Class 2
·Radiology
TRANS-CONNECTOR CLAMP BODY
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·October 21, 2014
INTELECT TERANSPORT 2C STIM
FDA Adverse Event
Injury
·DJO GLOBAL·Product code IMG·July 28, 2011
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·June 26, 2013
GRAFT PASSING WIRE
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code LXH·February 10, 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