10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LnK Lumbar Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
RXPEAKFLOW
FDA 510(k)
FDA Class 2
·Anesthesiology
IDRIVE ULTRA POWERED HANDLE 1
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·October 17, 2014
HEMOPRO2 EXTENSION CABLE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 7, 2011
11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·June 21, 2013
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019
XP-XP Tibial Tray - Interlok 65 mm Item # 195752
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
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