BEUDAMED
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    Vital Signs Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD Difco™ QC Antigen Salmonella O Group G1

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902117544·BD Difco™ QC Antigen Salmonella O Group G1

    LuxaFlow®

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2117540·Flowable light cure provisional add-on material...

    LOCKING SCREW, FULLY THREADED 5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009

    BLUE SUI SLING

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

    EXEL SECURETOUCH PTP SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNKNOWN TRILOGY LINER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWB·October 24, 2008

    PFC SIGMARP STB TB IN 3 12.5

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·August 10, 2011

    M2A-MAGNUM 42-50MM TAPER INSERT-3

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 8, 2013

    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·July 27, 2012

    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·March 15, 2013

    IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·July 10, 2012

    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·April 30, 2014

    19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·June 30, 2010

    Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·January 27, 2011

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025