BEUDAMED
    19 results · 31ms · Sources: EU EUDAMED, US FDA

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    Aquilion ONE (TSX-305A/6) V8.9 with AiCE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304270602·

    Percutaneous Compression Plate (PC.C.P)

    FDA UDI
    ORTHOFIX SRL·18032568869941·GOTFRIED PC.C.P. SHAFT SCREW 46MM

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515135376·Chung Weitlaner Retractor, 4 1/2", Blunt Tips, ...

    Percutaneous Compression Plate (PC.C.P)

    FDA UDI
    ORTHOFIX SRL·18033509850646·GOTFRIED PC.C.P. SHAFT SCREW 46MM STERILE

    BYTE DAY ALIGNERS

    FDA Adverse Event
    Malfunction ·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024

    HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FORA TELEHEALTH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RD SET YI

    FDA Adverse Event
    Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021

    RD SET DCI

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 3, 2008

    BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X3MM, UPPERFACE, (5/PACKAGE)

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code JEY·June 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 11, 2026

    RD SET

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

    RD SET

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

    DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·August 13, 2021

    DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·July 27, 2022

    COONS DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·July 28, 2022