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

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    Nyquist.IQ

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bernafon

    FDA UDI
    Bernafon AG·05711584115138·CZ5 MNR T R, 2.4G NFM MSIL/MAC CORAL 5 GPL

    NORMATEC MVP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INION CPS ORBITAL PLATES

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MED - NEUROMODULATION·Product code GZB·October 24, 2014

    3 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 12, 2011

    VET LCP 3.5 12HO L157 SST

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·July 9, 2013

    50MM LFT STANDARD MAND

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 12, 2024

    45MM RT STANDARD MANDIBULAR

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 12, 2024

    TMJ MED LFT FOSSA COMP

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 12, 2024

    TMJ MED RTFOSSA COMP

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 12, 2024

    CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015

    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