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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Diacare 7000

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551112211·HALO, 1203-5 VEST MEDIUM, COOLMAX LINER, 1211-1...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613252252054·2.0MP LEFORT I PLATE,7MM ADVANCEMENT,L

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205003133·Luna Opal MB Mini .018 Kit 3x3 U Hooks

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167522112070·

    EASYPOINT

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

    EASYPOINT

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

    LASER PERIPHERALS REUSABLE HOLMIUM FIBER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RESPIRE BLUE SERIES

    FDA 510(k)
    FDA Class 2 ·Dental

    Coral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981027766·Supra-Lamina Angled Hook Medium. The Coral Spin...

    Stainless Steel

    FDA UDI
    Seaspine Orthopedics Corporation·10889981028435·Supra-Laminar Angled Hook Medium. The Stainless...

    MICROWIRE CORTAC®

    FDA UDI
    PMT CORPORATION·00650551095125·SUBDURAL ELECTRODE, TOP & BOTTOM CONTACTS NUMBE...

    MICROWIRE CORTAC®

    FDA UDI
    PMT CORPORATION·00650551095583·SUBDURAL ELECTRODE, TOP & BOTTOM CONTACTS NUMBE...

    CELL-DYN 1800 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·October 28, 2008

    SENSOR, MMT-7002C, 10PK, GLUCOSE, BSA, 17L

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·July 11, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 8, 2013

    COOK SPECTRUM

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·November 4, 2019

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 27, 2024

    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