BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    Metapaste Plus

    FDA 510(k)
    FDA Class 2 ·Dental

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172972380·

    POLARIS DIAL-A-DATE CONTACT LENS CASE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·April 18, 2019

    BOSTON SCIENTIFIC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code LWS·October 22, 2008

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL MITRAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·August 12, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    HLC-723 G8

    FDA Adverse Event
    Malfunction ·TOSOH HI-TEC, INC.·Product code PDJ·July 26, 2024

    G8

    FDA Adverse Event
    Malfunction ·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025

    VIDAS LYME IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code LSR·April 22, 2021

    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

    FDA Enforcement
    Class I ·Ongoing·Whele LLC DBA Perch·November 30, 2022

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025