BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    TRI-matrix Implant Line

    FDA 510(k)
    FDA Class 2 ·Dental

    FirstStep Select

    FDA UDI
    Arjohuntleigh AB·05055982784894·FirstStep Select Excel, Overlay

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101155·DLEK CORNEAL DISSECTOR, ANGLED

    LEIBINGER NEURO CLIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CRYSTALLINE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 3, 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

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 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