BEUDAMED
    19 results · 30ms · Sources: EU EUDAMED, US FDA

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    Univers Revers Humeral Cup Implant

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TM "Soloventex" 221-232 S

    FDA UDI
    REABILITIMED TOV·04823097718575·Men's closed-toe socks, 2nd compression class 2...

    TM "Soloventex" 221-232 M

    FDA UDI
    REABILITIMED TOV·04823097718582·Men's closed-toe socks, 2nd compression class 2...

    TM "Soloventex" 221-232 XXL

    FDA UDI
    REABILITIMED TOV·04823097718612·Men's closed-toe socks, 2nd compression class 2...

    TM "Soloventex" 221-232 L

    FDA UDI
    REABILITIMED TOV·04823097718599·Men's closed-toe socks, 2nd compression class 2...

    TM "Soloventex" 221-232 XL

    FDA UDI
    REABILITIMED TOV·04823097718605·Men's closed-toe socks, 2nd compression class 2...

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 31, 2024

    CONSTELLATION CATHETERS, MODEL 8031M

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    JAG PRECURSOR

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code EZB·November 5, 2008

    INRATIO

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·August 15, 2011

    TOOTHETTE SUCTION

    FDA Adverse Event
    Malfunction ·SAGE PRODUCTS, LLC·Product code JOL·June 28, 2013

    TRUE METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·August 21, 2025

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 13, 2023

    CAPTURE-R READY-SCREEN 3

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code QHT·April 4, 2023

    Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.

    FDA Enforcement
    Class II ·Terminated·Carestream Health, Inc.·November 6, 2013

    Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 3, 2019

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    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