BEUDAMED
    12 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 ×

    SIMPLICI-T ANNULOPLASTY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809844313·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE LARGE FU...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450310540·

    GE SIGNA ASSET IMAGING OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901

    FDA 510(k)
    FDA Class 2 ·Neurology

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009

    EDWARDS SAPIEN RETROFLEX 3 TRANSCATHETER HEART VALVE DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code NPT·April 11, 2013

    HEMOLOK LIGATING CLIP

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FZP·May 27, 2008

    SPRINT QUATTRO

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011

    4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012