BEUDAMED
    15 results · 22ms · 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 ×

    MESA SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Conformis Hip System

    FDA UDI
    Conformis, Inc.·00810933030209·REAMER, ACETABULAR, 65MM FUL

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014606552·MIDMARK MONTREAL 2" DELUXE

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106110·Trial, 26 x 11mm, 8 Degree, Tapered, Straight

    SYRINGE 10ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·November 13, 2019

    SYRINGE 10ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 13, 2019

    R & D DESIGNATION AP-047

    FDA 510(k)
    FDA Class 2 ·Dental

    STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER

    FDA 510(k)
    FDA Class 2 ·Hematology

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 20, 2022

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 4, 2025

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Malfunction ·SUPERDIMENSION INC.·Product code JAK·May 6, 2011

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·April 26, 2013

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024