BEUDAMED
    354 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·March 30, 2016

    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 1, 2017

    Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults and children.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·August 5, 2015

    Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that perform tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalysis, nucleic acid testing.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·September 5, 2018

    BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 27, 2019

    BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 27, 2019

    KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·October 7, 2020

    Mammotome MammoStar Biopsy Site Identified, REF STAR1401

    FDA Enforcement
    Class II ·Terminated·Carbon Medical Technologies, Inc.·February 8, 2023

    Neurosign V4 Intraoperative Nerve monitor family of devices.

    FDA Enforcement
    Class II ·Terminated·The Magstim Company Limited·September 2, 2020

    Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 1, 2020

    Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box

    FDA Enforcement
    Class II ·Terminated·Gambro Renal Products, Incorporated·August 20, 2014

    Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box

    FDA Enforcement
    Class II ·Terminated·Gambro Renal Products, Incorporated·August 20, 2014

    Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box

    FDA Enforcement
    Class II ·Terminated·Gambro Renal Products, Incorporated·August 20, 2014

    BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064 Product Usage: 1) BD Blunt Plastic Cannula is used to penetrate pre-slit septums covering injection sites, as well as vials designed for penetration with needless IV access cannula. 2) The blunt steel canula will be targeted for exiting applications of pointer cannula, where blunt steel cannula would provide increased safety. Such existing applications include: -Accessing pre-slit/pre-pierced IV septum ports -Providing for fluid transfer -Can be used as tubing adapter 3) The BD single use Hypodermic Syringe is intended for use by healthcare professional for general purpose fluid aspiration/injection.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·February 11, 2015

    First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".

    FDA Enforcement
    Class II ·Terminated·Madison Polymeric Engineering·April 4, 2018

    Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 8, 2015

    Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 25, 2015

    cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR SYSTEMS analyzers.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 2, 2016

    Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

    FDA Enforcement
    Class II ·Terminated·Penlon, Ltd.·July 10, 2013

    Gingihue 15 Degree Pre-Angled Post Dental implants

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 24, 2016