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

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    Accelx Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694023269·FPS 3.5mm 4mm Wedge Plate

    TRANSPAC MONITORING KIT

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code DRS·November 22, 2016

    MORELAND

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295123354·MORELAND REV INST TREPHINE REAMER 11mm 9 IN

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694078047·FPS 3.5/4.0 4mm Wedge Plate Sterile Qty 2

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 30, 2002

    Ultraverse 035 PTA Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MACROPORE PURICEL LIPOPLASTY SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 2, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    GDC-10 ULTRASOFT COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code HCG·November 19, 2008

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 10, 2011

    SMARTSET GMV 40G US EO

    FDA Adverse Event
    Injury ·9610921 DEPUY CMW·Product code MBB·July 23, 2013

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QMN·January 31, 2023

    BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·June 14, 2023

    PKG, PKG, HOOK SCISSORS, P/N 0250080260. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014