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

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    STELLATE GRIDVIEW

    FDA 510(k)
    FDA Class 2 ·Neurology

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517174390·MAS Micro-Decomp Curette, Rev Ang Lg

    SONTEC OLSEN-HEGAR NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896046207·SONTEC OLSEN-HEGAR NEEDLE HOLDER SERRATED TIP

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989026955·SS BROAD ARCH ROUND160 UP LGE PK/20

    EMS Electrodes™

    FDA UDI
    GRAPHIC CONTROLS ACQUISITION CORP·00813150020466·

    NA

    FDA UDI
    STRYKER CORPORATION·04546540377982·Pin Collet

    EMS Electrodes™

    FDA UDI
    GRAPHIC CONTROLS ACQUISITION CORP·10813150020470·

    MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 7, 2023

    DELTAXSFT10 1.5MM X 2CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 4, 2021

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 25, 2019

    IMPELLA CP

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·January 5, 2026

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 18, 2014

    METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·May 16, 2017

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 29, 2013

    SAGITTAL SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·May 11, 2011

    ELECTROSURGICAL GENERATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 5, 2008

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code BTR·February 13, 2025