BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506074790·VEIN RETRACTOR, 8" BLADE LENGTH, ROUNDED ANGLED...

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506060847·VEIN RETRACTOR, 6" BLADE LENGTH, ROUNDED ANGLED...

    BD BACTEC MGIT 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·March 31, 2021

    IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    VPT METER

    FDA 510(k)
    FDA Class 1 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    SOLUSET 150 X 60 BURETTE SET, LATEX FREE

    FDA Adverse Event
    Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FPK·November 6, 2008

    IPUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    GLUCOSE MONITORING SYS/KIT

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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