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

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    O-PEP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768482·GENUMEDI PSS GREEN IV

    TMA - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989029581·TMA REV.CURVE/LOOPS 019X025 36MM PK/5

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180186880·METZ. SCISSORS, SINGLE ACTION, FLEXIBLE-INSULAT...

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100127·KRATZ-BARRAQUER SPECULUM RIGHT EYE

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas EGFR MUTATION TEST v2

    FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDTRONIC CLIP GUN KIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    COBAS® EGFR MUTATION TEST V2 P150044

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·April 1, 2026

    COBAS® EGFR MUTATION TEST V2 P150044

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·April 15, 2026

    COBAS® EGFR MUTATION TEST V2 P150044

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·March 27, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 30, 2013

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 12, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 27, 2016

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 2017

    Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 4, 2026

    RT-5100 Refractor, a component of the Epic-5100 System.

    FDA Enforcement
    Class III ·Terminated·Nidek Inc.·December 26, 2018