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

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    DIGITAL IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cetro America Toco Transducer for FC, FS, Fetacare, Waterproof

    FDA UDI
    CETRO AMERICA INC·00852519007342·Replacement Waterproof Toco Transducer for FC, ...

    AOS CANCELLOUS LAG SCREW 4.0mm x 22mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009453·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120220·Assembly, Screwdriver, Extended Tab

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0360220·Probe, Modified AO, Steffee, Curved

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 7, 2021

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710310320220·Talar Osteotmy Guide, 32mm x 22mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710300320220·Tibial Osteotmy Guide, 32mm x 22mm

    JOSTRA VENT CATHETERS, MODELS LV & HKV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NUGEN FX SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    5MM MINI PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FMI·January 22, 2007

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 26, 2013

    ARCHITECT HIV AG/AB COMBO

    FDA Adverse Event
    Death ·ABBOTT·Product code MZF·March 28, 2011

    ACCU-CHEK MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·April 21, 2008

    OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 25, 2024

    INSET PATELLA 26MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 25, 2024

    UNKNOWN EMPRINT ANTENNA

    FDA Adverse Event
    Injury ·COVIDIEN LP - SUPERDIMENSION INC·Product code LLZ·January 4, 2023

    UNKNOWN COOL TIP ELECRTRODE

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·January 5, 2023

    MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·April 6, 2022

    Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Princeton Biomeditech Corp·September 12, 2012