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

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    MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    n/a

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50220151·Device for prosthetic application (impression, ...

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193107141·HA PEEK EVOS Straight, ,15mmx9mmx 22mm , BICONV...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120150·Assembly, Screwdriver, Polyaxial, Lockable

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710810220150·Dwyer Calcaneal Guide, 22mm x 15mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710310220150·Talar Osteotmy Guide, 22mm x 15mm

    SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IMPLANT GUIDANCE SYSTEM APPLICATOR SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    LUCIRA CHECK-IT COVID-19 TEST

    FDA Adverse Event
    Malfunction ·PFIZER INC·Product code QJR·December 15, 2023

    CAPIOX HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·December 20, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·March 26, 2013

    ELECTRIC STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·March 10, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·March 31, 2008

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Injury ·ZOLL MANUFACTURING CORPORATION·Product code MVK·August 21, 2020

    NOVOSYN VIOLET 2/0 (3) 70CM HS 23 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL S.A.·Product code GAM·August 7, 2015

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024

    LUCIRA CHECK-IT COVID-19 TEST

    FDA Adverse Event
    Malfunction ·PFIZER, INC·Product code QJR·November 30, 2023

    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

    FDA Recall
    Terminated ·MRP, LLC dba AMUSA·Product code NGT·July 2, 2015

    Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box

    FDA Enforcement
    Class II ·Terminated·Gambro Renal Products, Incorporated·August 20, 2014