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

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    VIZILITE EYEWEAR

    FDA 510(k)
    FDA Class 2 ·Dental

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331100543·Hardy Bipolar Bayonet Forceps, 0.5 mm tip, 8-1/...

    Symmetry Hardy™

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482035955·Symmetry® Bipolar Forceps; Hardy Bayonet; w/o S...

    Symmetry Olsen

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00841785112775·

    VenaOne, Bulk pack of 20

    FDA UDI
    Precision Medical Products, Inc.·00194832000366·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100430·Caddie Lid, Adjustable Cross Links

    Centaur Pedicle Screw System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215126384·

    Disposable Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935100607·

    DRG AURICA ELISA TESTOSTERONE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 4, 2025

    SPECIAL FOOT PUMP ASSEMBLY

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·March 28, 2018

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·April 26, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 6, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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