BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM

    FDA 510(k)
    FDA Unclassified ·Unknown

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694001755·26mm Y Rigid Plate

    Aspida

    FDA UDI
    ALPHATEC SPINE, INC.·00844856063006·18MM SACRAL PLATE

    Entrada Hip Stem

    FDA UDI
    Ortho Development Corporation·00822409036035·Size 18 STD Collar

    OPERATING SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896046641·OPERATING SCISSORS STRAIGHT BLUNT BLADES

    Humeris Shoulder

    FDA UDI
    FX SOLUTIONS·03701037306635·RASP SIZE 18

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694063302·2.0 System 7 Hole 26mm Y Rigid Plate Sterile Qty 2

    IMC SURGICAL DRAPE

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

    VISTAKON (HEFILCON C) CONTACT LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SMR GLENOSPHERE DIA.36MM

    FDA Adverse Event
    Malfunction ·LIMACORPORATE S.P.A.·Product code PHX·June 16, 2022

    OXYGENATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·May 8, 2013

    ABBOTT M2000SP

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code JJH·September 18, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 16, 2011

    ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code KWQ·March 13, 2012

    Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·December 31, 2014

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013