BEUDAMED
    24 results · 21ms · Sources: EU EUDAMED, US FDA

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    Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Poly Per-Q-Cath Catheter

    FDA UDI
    Bard Access Systems, Inc.·00801741034800·DOT POLY PQC, 3F, SL,

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111019982·FERGUSON SCISS ANG/FLAT 7"

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100295·FRANKEL INFANT EYE SPECULUM

    CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD

    FDA 510(k)
    FDA Class 2 ·Neurology

    MSA HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·April 29, 2002

    ELECSYS 2010

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LTJ·June 8, 2013

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIAYLZATOREN GMBH·Product code MSF·September 4, 2008

    UNICEL DXC 600 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 17, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·May 6, 2019

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·May 6, 2019

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    ProScreen 10 Panel Cup, Item No. PSCup-10M

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·August 10, 2016

    Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 26, 2015

    STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 19, 2012