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    THORA-DRAIN III PLASTIC DRAINAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58208012210·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    NUPRO® Prophylaxis Paste with Fluoride

    FDA UDI
    DENTSPLY INTERNATIONAL INC.·D0038012211·NUPRO® Prophy Paste, Orange, Medium, Single Box...

    MPS Water Hose Connector Kit

    FDA UDI
    QUEST MEDICAL INC·20634624812219·

    Oph.Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00857365004040·Harms Colibri Fcps, .12mm W/Platforms

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209125913·

    LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MALE LATEX COMDOM WITH DOTTED SURFACE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2014

    TAXUS¿ ELEMENT¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 23, 2012

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 28, 2015

    BD PERFUSION¿ SYRINGE W/NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·August 9, 2018

    NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.

    FDA Recall
    Terminated ·Novarad Corporation·Product code LLZ·September 10, 2019

    NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer. The NovaPACS software makes images and data available in digital format from all common modalities. The images are viewed on a computer monitor or portable device. NovaPACS tools/features include the following: window, level, zoom, pan, digital subtraction, ejection fraction, cross localization, note-taking ability, voice dictation, and other similar tools. It includes the capability to measure distance and image intensity values, such as standardized uptake value. NovaPACS displays measurement lines, annotations, regions of interest, and fusion blending control functionality. Advanced features include 3D image rendering, virtual colonoscopy, and vessel analysis. Images and data are stored on a digital archive with multiple redundancies; images and data are available on-site and offsite. Novarad provides all software, including third party software (i.e. Windows OS). NovaPACS software resides on third party hardware, which may vary depending on the client s PACS needs. All hardware is connected to the radiology department local area network. NovaPACS integrates with NovaRIS and may integrate with any other third party RIS software that has HL7 interface capabilities. NovaPACS is intended for the viewing, archiving, analysis, annotation, registration, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc. NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images. NovaPACS is not intended for diagnostic image review on a mobile platform. While NovaPACS provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light conditions, and to confirm image compression ratios are consistent with the generally accepted standards of the clinical application

    FDA Recall
    Terminated ·Novarad Corporation·Product code LLZ·August 12, 2016

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025