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

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    PREGNAGEN(TM)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Shelf base, Servo-air

    FDA UDI
    Maquet Critical Care AB·07325710004166·

    Cross-Linked PE Insert

    FDA UDI
    ADLER ORTHO SPA·08050507130153·Cross-Linked PE Insert Flat Diam. 28 Gr. A

    R82

    FDA UDI
    R82 A/S·05715393012282·

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707033783·WEB 1ST MOL BANDS W/G8084-12 UR 2

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011882002180·dentaform® Band, Tooth 16, Size 2/Roth 18

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011882002000·dentaform® Band, Tooth 16, Size 2

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011882002220·dentaform® Band, Tooth 16, Size 2/Roth 22

    Cumulus Remover

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PROGENIX PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVOS SMALL 2.5MM DRILL W/AO QC LONG

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HWE·April 14, 2019

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·June 18, 2014

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·October 25, 2010

    TOTAL ASR FEM IMP SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·December 20, 2012

    2.0MM DRILL W/QC

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HRS·March 25, 2019

    EVOS SMALL 2.5MM DRILL W/AO QC LONG

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HWE·August 26, 2020

    EVOS SMALL 2.5MM DRILL W/AO QC LONG

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HWE·May 10, 2020

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025