BEUDAMED
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    Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.

    FDA Enforcement
    Class II ·Terminated·Zoe Medical Incorporated·September 26, 2012

    ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

    FDA Recall
    Terminated ·PHILIPS HOME HEALTHCARE SOLUTION·Product code OWB·December 8, 2020

    Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next to the control panel: HealthWay or CleanStation. HealthWay brand is sold under model number Deluxe 20600-3 Air Purification System. The CleanStation brand is sold under model number CS20000. The devices are intended to remove particles from the air for medical purposes

    FDA Recall
    Terminated ·Healthway Home Products, Inc.·Product code FRF·January 9, 2012

    ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Terminated·PHILIPS HOME HEALTHCARE SOLUTION·February 3, 2021

    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

    FDA Recall
    Terminated ·Med-Hot Thermal Imaging, Inc.·Product code LHQ·January 14, 2017

    Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; Home Access Health Corporation, Hoffman Estates, IL 60195-5200; UPC 0 83170 51000 5

    FDA Recall
    Terminated ·Home Access Health Corp (HAHC)·Product code MZO·October 6, 2006

    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

    FDA Enforcement
    Class II ·Terminated·Med-Hot Thermal Imaging, Inc.·May 17, 2017

    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019

    Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code DZI·March 14, 2019

    Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 14, 2019

    FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·August 27, 2003

    Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs)

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·April 23, 2003

    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·November 13, 2019

    Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code BZN·August 30, 2013

    Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a "Harris UV Lamp Training Manual"

    FDA Recall
    Terminated ·Harris Medical Resources·Product code MXG·May 13, 2010

    Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.

    FDA Recall
    Terminated ·Defibtech, LLC·Product code MKJ·August 27, 2010

    CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

    FDA Recall
    Terminated ·Caire, Inc.·Product code CAW·November 21, 2019

    Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malaysia

    FDA Recall
    Terminated ·Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2, Ind Zone Kota Bharu Malaysia·Product code KGO·December 18, 2006