44 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATG/SM-OSA APPLIANCES
FDA 510(k)
FDA Class 2
·Dental
ArgenZ ST 98x16 ML A4B
FDA UDI
ARGEN CORPORATION, THE·D818130130·Dental porcelain/ceramic restoration kit
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780378129·Integra® Jarit® Dressing Forceps, 11-3/4", Serr...
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925013261·AUSTIN SURGICAL CUTTING BLOCK
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776415266·Collin Speculum Large
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175825·Z-Rod, Dia. 6.0mm, Titanium, 130mm
INTEGRA 400+
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 12, 2006
XELIS 3D
FDA 510(k)
FDA Class 2
·Radiology
PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SIGMA
FDA UDI
ALPHATEC SPINE, INC.·00190376464817·130 mm NARROW BLADE, RIGHT, SIGMA MEDIALIZED
SIGMA
FDA UDI
ALPHATEC SPINE, INC.·00190376464800·130 mm NARROW BLADE, LEFT, SIGMA MEDIALIZED
NA
FDA UDI
STERILMED, INC.·10888551033008·BUR DIAMOND DISC FOR STRYKER TPS MIDAS REX & ZI...
NA
FDA UDI
STRYKER CORPORATION·04546540079305·25.4mm x 0.8mm Metal Cutting Diamond Disc
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code JJE·December 3, 2007
BD LOGIC BLOOD GLUCOSE MONITOR
FDA Adverse Event
Other
·BECTON DICKINSON·Product code NBW·May 13, 2004
COBAS 8000 COBAS ISE MODULE (DOUBLE)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 13, 2024
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 19, 2021
Vliwasorb
FDA UDI
Huizhou Foryou Medical Devices Co., Ltd.·06940610127756·
Widex
FDA UDI
Widex A/S·05706069884418·WIDEX MOMENT MRR2D (Mediterranean turquise ) 33...
Widex
FDA UDI
Widex A/S·05706069884494·WIDEX MOMENT MRR2D (Autumn Beige ) 330, RC coil...