12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Filtek One Bulk Fill Restorative
FDA 510(k)
FDA Class 2
·Dental
Back-N-Black
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357632077·
LINK Instruments - Drills, reamers and saw blades
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575397280·Fluted surgical drill bit, reusable - Megasyste...
S-SCAN MRI SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
JBAIDS Q FEVER DETECTION KIT
FDA 510(k)
FDA Class 1
·Microbiology
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013
VISISTAT 35R 6/BOX
FDA Adverse Event
Malfunction
·TELEFLEX·Product code GAG·July 16, 2014
UNKNOWN DEPUY KNEE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 8, 2011
ACCUTREND CHOLESTEROL
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CHH·July 31, 2019
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
FDA Enforcement
Class II
·Terminated·VGI Medical, LLC·June 13, 2018
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 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