BEUDAMED
    16 results · 31ms · 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 ×

    HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·August 20, 2025

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

    NA

    FDA UDI
    Richard Wolf GmbH·04055207014615·NEEDLE HOLDER Ø 5.0MM WL 300MM curved

    Suture Forceps

    FDA UDI
    Medetz Surgical Instruments LLC·G22312424510·Manhattan Suture Forceps 1x2 teeth, w/Platform ...

    OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Surgical Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    ATLAS PLUS VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014

    UNKNOWN DEPUY SOLUTION STEM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·July 23, 2013

    TMC SPEEDMTP

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025

    PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 26, 2019