BEUDAMED
    14 results · 18ms · 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.

    TLINK DATA MANAGEMENT SYSTEM (DMS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550193·GENUMEDI PT KNEE SUP SILVER R EW IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814770·GENUMEDI EXTRA WIDE SILVER SIZE IV

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104363·Rod Straight 5.5 x 140mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132140·Trial, TLIF, 27L OB CRV 7Deg, 14mm

    M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALEXIS WOUND RETRACTOR SMALL FOR 2.5-6CM INCISIONS

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code KKX·May 8, 2013

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 24, 2014

    ONCOTYPE DX MULTIVARIATE INDEX

    FDA Adverse Event
    Injury ·GENOMIC HEALTH·Product code NPQ·May 27, 2011

    4.5 BROAD SCP PLT 26-H STER

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021