133 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Leksell Vantage Stereotactic System
FDA UDI
Elekta Solutions AB·07340201501368·FirmFix™ Ruler
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522126413·CO2 SAMPLE LINE W/MALE LUER
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100270·Assembly, Caddie, Large Cervical Implants, Hinged
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100270·Tray Insert Iliac Screws 12 x 12 Assembly
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·BO73DRK0100270·Rasp, Angled Lumbar
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376617428·Vise Polyaxial Screw, 4.0mm X 27.5mm
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935103080·
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376643502·Polyaxial Screw, 4.0mm X 27.5mm
INSUFFLATION NEEDLE, MODEL R65-933
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STRYKER REMOTE SURGICAL PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 11, 2012
Shunt, Portosystemic, Endoprosthesis
FDA Pre-Market Approval
FDA Class 3
·GORE VIATORR TIPS
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·November 28, 2022
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTL, LTD.·Product code KWA·December 29, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 8, 2013
MAXID 19/38 KIT W/OUT SIDEHOL
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·March 25, 2011
EMBOSHIELD EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR GALWAY·Product code NTE·May 7, 2008
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·August 21, 2013
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·October 24, 2015