BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    Thermoplastic Elastomer (TPE) Hybrid Examination Glove

    FDA 510(k)
    FDA Class 1 ·General Hospital

    N/A

    FDA UDI
    Smith & Nephew, Inc.·03596010452887·TWIST DRILL LARGE 14.3MM X 127MM

    DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M SERIES

    FDA Adverse Event
    Death ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 20, 2008

    METAL BACKED PATELLA

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HTG·August 9, 2011

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024

    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