BEUDAMED
    19 results · 36ms · 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 ×

    UNITED U2 FEMORAL COMPONENT, PS, #7

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154157204·LOCKING SCREW, CROSS-PIN

    RHEAD

    FDA UDI
    Stryker GmbH·00886385023045·Lateral Stem Trial; 6mm Collar; Size 2

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707009443·CALIBRA 1ST MOLAR BANDS n.UR 7

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521205070·

    TALOS®-C

    FDA UDI
    SpineArt SA·07640375236296·STERILE TALOS®-C (HA) PEEK PLANAR IBFD

    XRES BLOOD COLLECTION RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4

    FDA 510(k)
    FDA Class 2 ·Neurology

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·March 30, 2016

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 9, 2013

    ISOLINE

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code MRM·September 26, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CALI·Product code FPA·June 10, 2011

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025

    BIB INTRAGASTRIC BALLOON SYSTEM

    FDA Adverse Event
    Injury ·APOLLO ENDOSURGERY·Product code LTI·January 26, 2024

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 24, 2025

    KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·February 17, 2021

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023