13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
FDA 510(k)
FDA Class 2
·Neurology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813033760·Hedstrom Files with Silicone Stops 21mm 45-80
Shannon Recta Larga Round Shank
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613289600·
BD MICROTAINER® TUBES WITH K2E (K2EDTA)
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·March 29, 2023
GME ExSys 308
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AESCULAP ORTHOPILOT 2 THA V 2.0
FDA 510(k)
FDA Class 2
·Neurology
ACCESSORIES
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025
UNKNOWN DEPUY TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSH·December 2, 2008
TJF-160F
FDA Adverse Event
Death
·OLYMPUS·Product code KOG·August 26, 2011
PELVICOL 4 X 12 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 19, 2013
GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL (MDR)·Product code LXH·May 29, 2015
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
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