BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    OIC Intramedullary Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE VIABIL BILILARY ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026

    TRUWAVE VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

    TRUWAVE VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

    G7 HI-WALL E1 LINER 40MM I

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·June 30, 2022

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·May 2, 2025

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 21, 2013

    MICRO GEMSTAR SPLT SET YLLW STRIPE 110IN

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code FPA·July 7, 2011

    FLEXIMA BILIARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code FGE·September 30, 2008

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·November 11, 2025

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 23, 2025

    AFFIXUS HUM CALIB DRILL 3.3MM

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code HSB·September 24, 2024

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·November 26, 2025

    UNKNOWN DRILL

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HAW·June 9, 2025

    WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.

    FDA Enforcement
    Class III ·Terminated·Copan Italia·September 11, 2013

    Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012