BEUDAMED
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    Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver

    FDA 510(k)
    FDA Unclassified ·Unknown

    SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE

    FDA UDI
    Intersurgical Incorporated·05030267157686·SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH ...

    SOLAR SHIELD

    FDA UDI
    FGX INTERNATIONAL INC.·00070135239293·

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011750·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 17

    SOLAR SHIELD

    FDA UDI
    FGX INTERNATIONAL INC.·00031568239298·

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613081300·Suction Tube, Long Curve, 3mm Outer Diameter (2...

    SOLAR SHIELD

    FDA UDI
    FGX INTERNATIONAL INC.·00846150239293·

    SOLAR SHIELD

    FDA UDI
    FGX INTERNATIONAL INC.·00887661239297·

    PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS

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

    MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 6, 2025

    QUICK FLEX LV LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 13, 2014

    RELIANCE T HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code LXH·June 3, 2013

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·June 23, 2011

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 4, 2023

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018