BEUDAMED
    22 results · 22ms · Sources: EU EUDAMED, US FDA

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    GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR

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

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496050193·RED WELLNESS 70 LEGGINGS, SIZE L, PAVONE, GRADU...

    MedGyn Pessary Cerclage w/o drain # 3

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050193·Pessary Cerclage is used to treat uterine prola...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450141489·

    2-pedal Footswitch，USB Plug Kit

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904098579·

    OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS

    FDA 510(k)
    FDA Class 2 ·Hematology

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code GDO·April 5, 2013

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·May 23, 2008

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 5, 2011

    BD FACS 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025

    Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator

    FDA Enforcement
    Class I ·Ongoing·Hamilton Medical, Inc.·September 27, 2023

    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Enforcement
    Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

    BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Enforcement
    Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

    Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment fields and recording the delivered treatment. Treatstation supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, Lantis Treatstation supports intensity modulation, a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 14, 2019

    Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015

    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019