BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    TLX SRAs and TLX Gold Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·04049958003110·400 micron Holmium Laser Fiber Cable, Single Us...

    CT-GUIDE NEEDLE GUIDANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GRIP LOCK ANCHOR, MODEL 411374

    FDA 510(k)
    FDA Class 2 ·Neurology

    I-STAT

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·April 21, 2023

    KNEE-DUMMY IMPLANT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC·Product code JWH·September 30, 2018

    UNKNOWN KNEE DEVICE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC·Product code JWH·September 30, 2018

    UNKNOWN KNEE DEVICE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC·Product code JWH·September 30, 2018

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 23, 2008

    TAXUS® LIBERTÉ®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 16, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 9, 2013

    LAPIPLASTY 4.0MM FULLY THREADED SCREW

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025

    MAGNETOM Cima.X (DE). Model Number: 11647158.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    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

    DRX Revolution Mobile X-Ray System

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