BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    SIXALYZER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011880230000·dentaform® Snap Band, Tooth 46, Size 30

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011880230220·dentaform® Snap Band, Tooth 46, Size 30/Roth 22

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011880230180·dentaform® Snap Band, Tooth 46, Size 30/Roth 18

    NEB-U-MASK SYSTEM, MODELS 1895, 1896

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NEST Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 18, 2014

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code LZS·October 15, 2010

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 19, 2012

    Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026