Archive for the 'Medical Devices' Category

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FDA Reminders For Falsely Elevated Glucose Readings From Use of Inappropriate Test Method

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 9th, 2005 in Medical Devices

Topics: Glucose Monitoring

FDA & YOU - News for Health Educators and Students - Fall 2005 Issue

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 8th, 2005 in Medical Devices

Our mission is to inform and encourage health educators and students to learn about the latest FDA medical product and health news. We strive to publish articles that are timely, interesting and relevant to middle and high school students, their parents..

Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tinnitus Masker Devices; Availability

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 8th, 2005 in Medical Devices

Federal Register: Ear, Nose, and Throat Devices; Tinnitus Masker; Designation of Special Controls

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 8th, 2005 in Medical Devices

Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 013

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 8th, 2005 in Medical Devices

510(k) Final Decisions - October 2005

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 7th, 2005 in Medical Devices

Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner; Availability

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 7th, 2005 in Medical Devices

Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of the Low Energy Ultrasound Wound Cleaner

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 7th, 2005 in Medical Devices

Tinnitus Masker Devices - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 7th, 2005 in Medical Devices

Topics: Tinnitus

Federal Register: Proposed Collection; Comment Request; Emergency Shortages Data Collection System (Formerly the Emergency Medical Device Shortage Program Survey)

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 4th, 2005 in Medical Devices

The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #10 - Guidance for Industry and FDA Staff

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 4th, 2005 in Medical Devices

Topics: Mammography

Low Energy Ultrasound Wound Cleaner: Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 3rd, 2005 in Medical Devices

Topics: Ultrasound, Wound Cleaners

FDA Patient Safety News for November

Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 1st, 2005 in Medical Devices

FDA Patient Safety News is a televised series for health care personnel aimed at hospitals and other medical facilities across the country.

Summary Information for P960040s028 - VENTAK PRIZM® AVT™ System

Closed Published by Food and Drug Adminstration (FDA): CDRHNew October 31st, 2005 in Medical Devices

Topics: Implantable Cardioverter Defibrillator

FDA Preliminary Public Health Notification: New Information about Ralstonia spp. Associated with Vapotherm® Respiratory Gas Administration Device

Closed Published by Food and Drug Adminstration (FDA): CDRHNew October 27th, 2005 in Medical Devices

This is to provide new information about a possible association between the Vapotherm® 2000i Respiratory Gas Administration device, which is used to add moisture and warm breathing gases through a nasal canula in patients receiving supplemental oxygen…

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