BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bernafon

    FDA UDI
    Bernafon AG·05711584115497·CO1 MNR, 2.4G NFM MSIL CAPTO 1 GPL

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971376·

    ONE TOUCH BASIC ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 7, 2002

    MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REPROCESSED STONE RETRIEVAL BASKETS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PULSE GEN MODEL 101

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·October 24, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 16, 2011

    STAIR PRO - MODEL 6252

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPP·July 9, 2013

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023