BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    andorate Suction Valve, andorate Air/Water Valve

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

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704514810·

    Mariner Deformity

    FDA UDI
    Seaspine Orthopedics Corporation·10889981298340·Iliac Tap, Cannulated, Navigated, 9.5mm

    E-CARE INFRARED EAR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026

    ENDOPATH** XCEL* TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 16, 2011

    CS100

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·August 4, 2014

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·May 26, 2022

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2025

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 29, 2026

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

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

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

    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