BEUDAMED
    16 results · 37ms · 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 ×

    UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613024161·Metzenbaum Scissors, TC, Curved, Fine, Blunt Ti...

    LORENZ 2.4 SELF DRILLING SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VITEK 2 STREPTOCOCCUS LEVOFLOXACIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    IMP TM 4.7MM MTX FULL, 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 27, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    CD HORIZON BALLAST SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

    INGEVITY

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·October 1, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    LONG NAIL KIT R1.5, TI, LEFT 10X280MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 14, 2011

    IMP TM 4.7MM MTX FULL, 10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 30, 2024

    IMP TM 6.0MM MTX FULL, 10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 29, 2023

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015