BEUDAMED
    15 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 ×

    HBA SPERM-HYALURONAN BINDING ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032874·Baltic Denture System BDLoad Mm6 PLSEbim6DFm B1...

    GEN-PROBE APTIMA COMBO 2 ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    WELL-TENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    NONE - SEE PHYSICIAN COMMENTS IN H10.

    FDA Adverse Event
    Injury ·Product code JWH·October 16, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 7, 2025

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 29, 2013

    TECNIS

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·March 29, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN - BENNETT CORP.·Product code CBK·April 23, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Injury ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 15, 2023

    UNSPECIFIED BD¿ NEXIVA CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·June 13, 2023

    8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa 3.0T with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or 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@ Infinity systems 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

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024