BEUDAMED
    16 results · 21ms · 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 ×

    ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDLINE

    FDA UDI
    CENTURION MEDICAL PRODUCTS CORPORATION·10888277903524·4X8 DRESSING PACK

    ArgenZ HT+ 98x10 C1

    FDA UDI
    ARGEN CORPORATION, THE·D818121981·Dental porcelain/ceramic restoration kit

    IVENT 201 PORTABLE VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OPTETRAK LOGIC COMBINATION TIBIAL TRAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SECURE 3 MED/SURG BEDOBS 01/13

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 21, 2013

    HALO90 ABLATION CATHETER

    FDA Adverse Event
    Other ·BARRX MEDICAL INC.·Product code GEI·June 3, 2011

    SPACEMAKER BLUNT TIP TROCAR 12MM

    FDA Adverse Event
    Malfunction ·PONCE - USS·Product code GCJ·August 13, 2008

    LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 6, 2025

    BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·August 30, 2017

    LOGIC FEMORAL PS CEM RIGHT SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 25, 2022

    INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NDP·June 11, 2021

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: 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. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015