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

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    Synchro SELECT Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SureCore Automatic Disposable Biopsy Needle

    FDA UDI
    Canyon Medical Inc.·06954414640762·Automatic Disposable Biopsy Needle

    SureCore Automatic Disposable Biopsy Needle

    FDA UDI
    Canyon Medical Inc.·06954414640939·Automatic Disposable Biopsy Needle

    SureCore Automatic Disposable Biopsy Needle

    FDA UDI
    Canyon Medical Inc.·06954414643114·Automatic Disposable Biopsy Needle

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113325·PHACO KNIFE 2.8MM ANGLED (BX/5)

    Forefoot Screws

    FDA UDI
    Life Spine, Inc.·00190837020422·

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383513265·"An absorbent paper points is an endodontic pap...

    Compression Staple System

    FDA UDI
    TORNIER, INC.·00846832055302·Staple

    PULPDENT PUTTY DAM

    FDA 510(k)
    FDA Class 1 ·Dental

    OPART, MODEL MRT-600

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 20, 2023

    MIC SAFETY PEG KIT - PULL METHOD

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KNT·August 4, 2022

    BHR ACETABULAR CUP 58MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·July 24, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 5, 2011

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 8, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

    SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    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

    SIGNA Creator, SIGNA Explorer, NMRI systems

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare (China) Co., Ltd.·March 5, 2025

    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