BEUDAMED
    22 results · 23ms · 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.

    REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00143521·

    Nu Skin Facial Spa Package

    FDA UDI
    NSE PRODUCTS, INC.·00860196000327·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001352·artVeneer life lower anteriors, UCS, C2

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085023847·Centrifuge Tubes, 50 mL, 20 Bags x 25 Tubes

    Health-Tec Hand Instruments

    FDA UDI
    Dental Health Products Inc·D77370013520·Health-Tec/DHP Expro Color Coded DE 23/CP11

    Fortress Pedicular Fixation

    FDA UDI
    SPINEOLOGY INC.·M7401001352·Fortress Persuader

    MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    INVERSE/REVERSE SCREW SYSTEM, 4.5-30

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWT·February 4, 2016

    BATTERY RECIPROCATOR

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code MOQ·March 13, 2013

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 25, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC·Product code JAA·February 22, 2008

    ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·April 23, 2025

    G7 OSSEOTI MULTIHOLE 64MM H

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·January 4, 2017

    ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·August 5, 2025

    ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·January 16, 2025

    Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013