BEUDAMED
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    DTX Studio Clinic

    FDA 510(k)
    FDA Class 2 ·Radiology

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·04049958003127·400 micron Holmium Laser Fiber Cable, Single Us...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113813·VISCO CANNULA 27GA ANGLE 8MM

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113660·CYSTOTOME STRAIGHT 25GA

    BLASTASSIST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    V.A.C. VERAFLO CLEANSE DRESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·October 17, 2008

    COULTER® AC*T DIFF 2 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 2, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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