BEUDAMED
    21 results · 20ms · 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 ×

    g.Estim FES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040187890·ZIRLUX ML DISC B4 98x22

    2880 CLRA

    FDA UDI
    HANS RUDOLPH, INC.·00817136022062·COUPLER LOCK RING 8500/1410

    blueendo

    FDA UDI
    TROKAMED GmbH·04251303822257·MyTube cap Ø 40 mm for basic tube 02-00087 reus...

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828190169·GEN4 DIGITAL

    Initia Total Hip System

    FDA UDI
    KYOCERA MEDICAL CORPORATION·04580810057570·"STD LINER 28-48 Size:28-48 Type:Flat 28mm I.D....

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036033507·

    Initia Total Hip System

    FDA UDI
    KYOCERA CORPORATION·04547898306174·STD LINER 28-48

    HAD1717MC

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·October 12, 2017

    HYDRATOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 15, 2008

    PONTO WIDE IMPLANT 3MM

    FDA Adverse Event
    Other ·OTICON MEDICAL AB·Product code LXB·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011

    Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    FDA Enforcement
    Class II ·Terminated·SynCardia Systems Inc.·January 9, 2013

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014