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

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    MilkMate Breast Pump

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Tee Pee Thumb Protector

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357230846·

    GLOBAL CAP

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295105152·GLOBAL CAP HEAD GAUGE 40,56

    GLOBAL CAP

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295105145·GLOBAL CAP TEMPLATE

    GLOBAL CAP

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295105169·GLOBAL CAP HEAD GAUGE 44,48,52

    MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SINGLE LUMEN POYETHYLENE CENTRAL VENOUS CATHETER TRAY

    FDA Adverse Event
    Injury ·COOK INC·Product code FOZ·August 17, 2011

    ATLAS DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·July 12, 2013

    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018