BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CODMAN

    FDA UDI
    Cerenovus, Inc.·10886704002352·CODMAN Slimline Mini Aneurysm Clip No 7 Forward...

    Conventional Lead Apron .5mm Medium 24 X 39

    FDA UDI
    Flow X Ray Corporation·00843696123338·Conventional Lead Apron .5mm Medium 24 X 39, Br...

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383549189·"An absorbent paper points is an endodontic pap...

    BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HAHN TAPERED IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 26, 2025

    HAHN TAPERED IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 28, 2024

    ARCHITECT I2000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·September 21, 2010

    ARCHITECT I2000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·September 21, 2010

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Injury ·ABBOTT MANUFACTURING, INC.·Product code JJE·May 17, 2010

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code MTF·July 2, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·December 27, 2012

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code OMI·February 8, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 28, 2012

    ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021