BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    SCOPE BUDDY PLUS Endoscope Flushing Aid

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

    VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 10, 2025

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 10, 2025

    KNIGHTSTART 330

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code CBK·October 22, 2008

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·August 4, 2011

    ALIGN RS URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·July 3, 2013

    NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)

    FDA Adverse Event
    Malfunction ·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023

    CustMbite, Model Number CBT-SRS-UL

    FDA Enforcement
    Class II ·Ongoing·Dental Choice Holding Llc·August 10, 2022

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012