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

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    Biotres

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613252096009·LeFort I Plate, 9mm advancement, left

    FOUNDATION DENTAL RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    UNI-GOLD STREP A TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    EASYPOINT NEEDLE

    FDA Adverse Event
    Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

    EASYPOINT NEEDLE

    FDA Adverse Event
    Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

    PUMP MMT-522LWWS PRDGM INS SK EN LN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·October 23, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 8, 2013

    AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·March 7, 2018

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021