BEUDAMED
    18 results · 22ms · 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 ×

    SOFIA(R) HCG FIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EpiSpin Soft NRFit

    FDA UDI
    Pajunk GmbH Medizintechnologie·04048223029220·EpiSpin Soft NRFit Tuohy ...

    EPILONG

    FDA UDI
    Pajunk GmbH Medizintechnologie·04048223084151·131166-608

    EPILONG

    FDA UDI
    Pajunk GmbH Medizintechnologie·04048223116357·131166-608

    K181166

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·December 2, 2022

    4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ

    FDA 510(k)
    FDA Class 2 ·Radiology

    A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·February 23, 2024

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    MEDITRACE CADENCE

    FDA Adverse Event
    Injury ·COVIDIEN·Product code MKJ·May 22, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 16, 2011

    NUCLEUS FREEDOM

    FDA Adverse Event
    Injury ·COCHLEAR AMERICAS·Product code MCM·August 20, 2008

    NA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·May 1, 2026

    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

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025