BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DeBakey Peripheral Vasc Clamp 26.5cm cvd heavy pattern

    FDA UDI
    Geister Medizintechnik GmbH·04057034053126·DeBakey Peripheral Vasc Clamp 26.5cm cvd heavy ...

    LINK Instruments - Chisel, bone curette, raspatory, rongeur

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575341368·General-purpose surgical spatula - LINK SLED Pr...

    ACCUSONIC ADVANTAGE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    COOLBLU2 DENTAL RESIN CURING DEVICE

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 3, 2014

    SERFAS ENERGY SUPER 90-S

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·August 15, 2011

    UNIFY CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

    FDA Enforcement
    Class II ·Terminated·Rockwell Medical, Inc·May 23, 2018

    Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 23, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025