BEUDAMED
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    4K UHD LCD Monitor OEV321UH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDLINE STOPCOCK AND MANIFOLD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2025

    Widex

    FDA UDI
    Widex A/S·05706069794564·Widex BEYOND B-F2 (Summer gold ) 220, Telecoil,...

    NA

    FDA UDI
    Zimmer, Inc.·00889024187771·

    Widex

    FDA UDI
    Widex A/S·05706069827422·WIDEX EVOKE EBB3D (Summer gold ) 220, Telecoil,...

    EZ-IO 45MM NEEDLE (EA)

    FDA Adverse Event
    Injury ·TELEFLEX MEDICAL·Product code FMI·October 23, 2017

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 31, 2008

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·August 9, 2011

    ATLAS II PLUS DR

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

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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