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 ×

    NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PROTEIN

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT

    FDA 510(k)
    FDA Unclassified ·Unknown

    3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    XORAN

    FDA Adverse Event
    Malfunction ·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011

    RENAL UROLOGY STENT K072293

    FDA Adverse Event
    Other ·FOSSA MEDICAL INC·Product code FAD·April 10, 2014

    SCP PANEL CENTRIFUGE JMS

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·November 5, 2013

    SCP PANEL CENTRIFUGE JMS

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·March 14, 2014

    SCP CONTROL PANEL

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012

    GII ARTICULAR INSERTER/EXTRACT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018

    CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWA·January 19, 2018

    CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWA·January 5, 2022

    5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems) Signa HDxt (K052293 Signa HDx and HDxt MR Systems ) 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

    STOCKERT JMS CENTRIFUGAL PUMP SYSTEM

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012

    OCTRODE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·March 23, 2011

    RICHARD ALLEN 1/2 CIRCLE TAPER POINT (HEAVY)

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, INC.·Product code FMI·April 21, 2008

    STOCKERT CENTRIFUGAL PUMP (SCP) SYSTEM

    FDA Adverse Event
    Injury ·SORIN GROUP DEUTSCHLAND·Product code DWA·May 7, 2010

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    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