BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    SafeBreath Filter Mouthpiece

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Greenwald Surgical Company, Inc.

    FDA UDI
    GRACE MANUFACTURING, INC.·10801334008093·Otis bougie-a-boule. stainless steel

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694089456·22mm, OsteoFlap

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189756·AK3 Femoral Sizing/Alignment Guide

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694005531·22mm, OsteoFlap, Sterile

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·4Kscore Test

    NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PARADIS VASO SHIELD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·4Kscore Test

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·4Kscore Test

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·The 4Kscore Test

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 8, 2008

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 18, 2013

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·August 4, 2011

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024