BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    BEACON TISSUE MARKER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·April 13, 2022

    ENDURANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 24, 2013

    CARELINK

    FDA Adverse Event
    Malfunction ·PLEXUS MANUFACTURING SDN. BHD.·Product code NVZ·June 16, 2011

    KARL STORZ

    FDA Adverse Event
    Other ·KARL STORZ GMBH & CO. KG·Product code FED·August 5, 2008

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 6, 2022

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 15, 2020

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·February 9, 2023

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·December 6, 2024

    2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code OLO·May 6, 2016

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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