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

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    GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMAGEN3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    SHELL IMPACTION PLATFORM

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 26, 2019

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE.

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 29, 2013

    MICROPLEX 10-SYSTEM DETACHABLE COIL (MCS)

    FDA Adverse Event
    Death ·MICROVENTION, INC.·Product code HCG·June 3, 2011

    X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015