BEUDAMED
    20 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 ×

    OSTEOMED EXTREMIFUSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Eagle Heavy Duty Latex Examination Gloves

    FDA UDI
    Eagle Protect Pbc·09421024254872·Heavy Duty Latex Examination Gloves, Blue, Powd...

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1304120·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776302290·DeVilbiss Vaginal Specula - large

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973101215·Poly Insert PS, Size 4, 12mm

    AXIOM FASCIAL CLOSURE SYSTEM

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

    BIOLOX DELTA CERAMIC FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vasomedical-Biox™ 1304 12 Channel ECG Holter Recorder

    FDA UDI
    VASOMEDICAL, INC.·00817980020023·12 CH ECG Holter Recorder

    AIRVO2 HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 26, 2015

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 24, 2013

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·September 30, 2014

    CINCH ANCHOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 13, 2011

    Vasomedical-Biox™ Model 1304 12 CH Recorder - 10 Lead Patient Cable

    FDA UDI
    VASOMEDICAL, INC.·00817980020405·Model 1304 12 CH Recorder - 10 Lead Patient Cable

    AUTOSOFT XC

    FDA Adverse Event
    Injury ·UNOMEDICAL UM-D·Product code FPA·March 6, 2025

    Universal Nerve Block Tray Catalog Number: 9818

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·September 24, 2013

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    UNKNOWN ZIMMER METASUL LARGE DIAMETER HEAD (LDH)

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·December 11, 2017

    Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007

    FDA Recall
    Terminated ·Associates of Cape Cod, Inc.·Product code NQZ·August 17, 2022

    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