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

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    C. DIFF QUIK CHEK COMPLETE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GRAFTYS HBS (510K NUMBER: K082498)

    FDA Adverse Event
    Injury ·GRAFTYS·Product code MQV·July 11, 2013

    OPTETRAK LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 3, 2025

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·April 25, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 10, 2011

    DERMABOND TOPICAL SKIN ADHESIVE

    FDA Adverse Event
    Other ·CLOSURE MEDICAL CORP.·Product code MPN·July 22, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021