BEUDAMED
    22 results · 21ms · 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 ×

    APTUS Elbow Dorsal Olecranon Plates

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bernafon

    FDA UDI
    Sbo Hearing A/S·05714464058419·BERNAFON ALPHA 3 MNR T SABE/MSIL DEMO

    HEAVY SYNTHETIC CAST SHEARS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896026872·HEAVY SYNTHETIC CAST SHEARS BLUNT TIP

    EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·January 17, 2024

    BAB FLEXIBLE FABRIC BANDAGES

    FDA Adverse Event
    Injury ·KENVUE BRANDS, LLC·Product code KGX·September 2, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 10, 2014

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·July 22, 2013

    SINGLE USE GUIDEWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code OCY·March 12, 2025

    INFUSOMAT ®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FRN·January 19, 2024

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

    FDA Enforcement
    Class II ·Ongoing·Straumann USA LLC·April 30, 2025

    Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Technologies Ltd.·November 27, 2024

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014