9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NavaClick Injection System
FDA 510(k)
FDA Class 2
·General Hospital
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102299·BONFADINI DALK SPATULA
EMBRACE WET-BOND RESTORATIVE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
SAVE II, SAVE II BASIC
FDA 510(k)
FDA Class 2
·Anesthesiology
2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·December 18, 2018
PUMP MMT-712LNAS PRDGM INS SK EN US LN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·November 12, 2008
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·September 1, 2011
UNK VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code GAT·July 10, 2013
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·July 10, 2019