BEUDAMED
    20 results · 32ms · Sources: EU EUDAMED, US FDA

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    MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743649·ACHIMED ACHILLES SUPP SILVER I

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743458·LEVAMED ANKLE SUPPORT SILVER I

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5820802110·RETRACTOR, ALL TYPES

    ITOTAL IDENTITY TIBIAL EXTENSION WRENCH

    FDA UDI
    Conformis, Inc.·00810933030490·

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221024718·Unitek(TM) Lingual Sheaths Solid Tube U/L Hook ...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102110·Shaver, Open 11mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023949·PADDLE SPREADER, 11MM

    Havasu

    FDA UDI
    STRYKER CORPORATION·07613327524130·IV Pole

    STERILE NITRILE POWDER-FREE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BUILD-IT FR

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·April 26, 2013

    ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 6, 2011

    ADVIA CENTAUR VANCOMYCIN ASSAY

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.,·Product code LEH·July 17, 2008

    FULL FACE MASK

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code MNT·June 20, 2008

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018