8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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StarFormer, TightWave
FDA 510(k)
FDA Class 2
·Physical Medicine
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G22312212740·Dodick-Kammann Nucleus Chopper 2.0mm Long Inter...
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
FDA 510(k)
FDA Class 2
·General Hospital
PIXEL APP
FDA 510(k)
FDA Class 1
·General Hospital
TRIDENT ALL POLY CUP-CROSSFIRE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·August 17, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
SYNERGY VERSITREL
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·July 11, 2013
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