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

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    BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114

    FDA 510(k)
    FDA Class 2 ·Immunology

    Sheehy

    FDA UDI
    MEDTRONIC XOMED, INC.·00763000041243·VENT TUBE 1040030 100PK PR COLLAR BUTTON

    Sheehy

    FDA UDI
    MEDTRONIC XOMED, INC.·00721902876790·VENT TUBE 1040030 100PK PR COLLAR BUTTON

    AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 30mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009705·

    OneFill

    FDA UDI
    US ENDODONTICS, LLC·00810047644583·Gutta percha plastic carrier obturator

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867521797·Cannulated Cancellous Screw, 7.0x30mm

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·INSITE HER-2/NEU KIT

    Aspida

    FDA UDI
    ALPHATEC SPINE, INC.·00811801038358·Adjustable ASPIDA Awl Guide

    Gorilla Plating System

    FDA UDI
    Paragon 28, Inc.·00889795009555·BOW & Arrow, Base Wedge Plate, 3.0mm Wedge

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710420400300·Anterio Lateral Closing Wedge Osteotomy Guide, ...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710410400300·Anterior Closing Wedge Osteotomy Guide, 40mm x ...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710400400300·Anterior Dome Osteotomy Guide, 40mm x 30mm

    CONTOUR CURVED CUTTER STAPLER CS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006

    LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHERIDAN/HVT CUFFED MURPHY EYE TRACHEAL TUBE

    FDA Adverse Event
    Injury ·TELEFLEX MEDICAL·Product code BTR·April 3, 2013

    MAHURKAR MAXID

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FJS·March 25, 2011

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·May 7, 2008

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024