BEUDAMED
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    Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.

    FDA Enforcement
    Class II ·Terminated·Valeant Pharmacueticals International·May 25, 2016

    Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant.

    FDA Recall
    Terminated ·Bioplate Inc·Product code JEY·March 31, 2010

    Atlas VR, Models V-199

    FDA Recall
    Terminated ·Product code LWS·October 6, 2005

    Photo Micro VR/DR Models V-194

    FDA Recall
    Terminated ·Product code LWS·October 6, 2005

    Atlas DR, Models V-240

    FDA Recall
    Terminated ·Product code LWS·October 6, 2005

    Photo DR, Model V-230HV Implantable Cardioverter Defibrillator

    FDA Recall
    Terminated ·Product code LWS·October 6, 2005

    Photo Micro VR/DR Models V-232

    FDA Recall
    Terminated ·Product code NIK·October 6, 2005

    Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.

    FDA Recall
    Terminated ·Valeant Pharmacueticals International·Product code N/A·January 29, 2016

    QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.

    FDA Recall
    Terminated ·Qrs Diagnostic·Product code LOS·February 16, 2012

    QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine.

    FDA Recall
    Terminated ·Pulse Biomedical Inc·Product code LOS·March 5, 2007

    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

    FDA Recall
    Terminated ·SA3, LLC·Product code OLR·February 21, 2022

    Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100, Cardinal Health, San Diego, CA. (All Alaris Pump modules shipped prior to December 23, 2007 are subject to this recall)

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·October 29, 2007

    System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA

    FDA Recall
    Terminated ·Custom Ultrasonics, Inc.·Product code KOG·February 11, 2008

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code JOY·May 2, 2016

    Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 22, 2016

    The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.

    FDA Recall
    Terminated ·PerkinElmer LAS, Inc·Product code JLW·October 24, 2011

    RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code JBD·June 29, 2004

    RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code GKA·September 14, 2004

    Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code JIA·September 8, 2004

    OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

    FDA Recall
    Terminated ·Johnson & Johnson Surgical Vision Inc·Product code OOE·May 9, 2018