Device Advice
...Device Advice is CDRH`s self-service site for medical device and radiation emitting.....Device Advice is an interactive system for obtaining information concerning medical..
http://www.fda.gov/cdrh/devadvice/ (score=100)

Medical Device Reporting MDR
...Medical Device Reporting (MDR) About Medical Device Reporting.. General Information.....Medical Device Tracking.. Postmarket Surveillance.. Databases.. General Information on..
http://www.fda.gov/cdrh/mdr.html (score=86)

FDA APPROVES NEW IMPLANTED HEARING DEVICE
...The device was approved for use in teenagers and adults who have a rare disease called.....This was due either to migration of the implant after surgery or misplacement of the.....The device, made by Cochlear Corporation of Englewood, Colo., restores the ability to..
http://www.fda.gov/bbs/topics/ANSWERS/ANS01049.html (score=79)

FDA APPROVES HEART ASSIST DEVICE
...By pumping blood through the body, the device helps do the heart's work until a donor.....This device could help save the lives of many transplant candidates who now die for lack.....FDA's decision to approve the device is based on a review of safety and effectiveness data..
http://www.fda.gov/bbs/topics/NEWS/NEW00493.html (score=78)

FDA APPROVES FIRST HEART-ASSIST DEVICE
...By pumping blood through the body, the newly-approved device lets the heart rest so it can.....The new device is recommended for short-term use in patients whose bodies are large enough.....The device assumes the heart's work load until the heart can recover, and is then..
http://www.fda.gov/bbs/topics/answers/ANS00447.html (score=77)

CDRH PRODUCT CODE CLASSIFICATION DATABASE
...The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts.....The Product Classification Database contains medical device names and associated.....This database contains device names and their associated product codes. The name and..
http://www.fda.gov/cdrh/prodcode.html (score=76)

General Information - Medical Device Reporting
...Device user facilities must also report device-related serious injuries to the manufacturer, or to the FDA if the manufacturer is.....A GAO followup study in 1989 concluded that despite full implementation of the Medical.....In addition, SMDA also required that device user facilities submit to FDA, on a semiannual..
http://www.fda.gov/cdrh/mdrinfo.html (score=76)

FDA Approves Implanted Device to Control Incontinence
...800-532-4440 FDA APPROVES IMPLANTED DEVICE TO CONTROL INCONTINENCE The Food and Drug.....The device is intended for women and men who have urge incontinence, a sudden.....About 20 percent of people with urge incontinence would be able to benefit from the device..
http://www.fda.gov/bbs/topics/NEWS/NEW00593.html (score=76)

Medical Device Recalls
...This site provides information on Class 1 medical device recalls, and some Class II and.....If you need further information on medical device recalls, or other FDA product areas.....Medical Device Recalls .. A recall is a correction or removal of a product that: a) is..
http://www.fda.gov/cdrh/recalls/ (score=76)

Laser probe approved for clearing arteries
...March 26, 1987 FDA APPROVES FIRST LASER DEVICE FOR CLEARING ARTERIES FDA has approved the.....The new device will allow these difficult cases to be treated with the balloon by first.....With the Trimedyne device, this risk is greatly reduced, because the laser's rays are used..
http://www.fda.gov/bbs/topics/ANSWERS/ANS00316.html (score=75)

Device Advice
...The device classification regulation defines the regulatory requirements for a general.....A description of device classification and a link to the Product Classification Database.....Additional information on medical device user fees, including how to qualify as a small..
http://www.fda.gov/cdrh/devadvice/overview.html (score=75)

CBER - Device Action Plan
...device laws and regulations, cooperation between CBER, the Center for Devices and.....Coordination with the Center for Devices and Radiological Health (CDRH) Improvement of.....Device Action Plan.. The Device Action Plan (DAP) was initiated on April 26, 1999 in response to stakeholders..
http://www.fda.gov/cber/dap/dap.htm (score=74)

DESIGNING A MEDICAL DEVICE SURVEILLANCE NETWORK
...Provide the findings regarding emerging device problems to the medical device industry to aid them in making appropriate.....This system will allow the dissemination of data regarding newly emerging device problems.....It will allow FDA to apply the knowledge gained from the reported data to the device..
http://www.fda.gov/cdrh/postsurv/medsun.html (score=74)

FINAL REPORT OF A STUDY TO EVALUATE THE FEASIBILITY AND EFFECTIVENESS OF A...
...The FDA Medical Device Reporting system requires facilities to report medical device.....CDRH’s oversight authority for medical devices comes through the 1976 Medical Device.....In addition to the changes created by MEDWATCH, the Safe Medical Device Amendments in 1990..
http://www.fda.gov/cdrh/postsurv/medsunappendixa.html (score=74)

FDA APPROVES NEW SPINAL FUSION DEVICE
...The device, the first of its kind to receive approval, will provide a new option for.....The device was approved for people with degenerative disc disease who need fusion of.....FDA's decision to approve the device was based on a review of a clinical study on safety..
http://www.fda.gov/bbs/topics/ANSWERS/ANS00760.html (score=74)

Medical Devices
...I am pleased to be here today to participate in a discussion of the FDA's Medical Device.....The Thoratec Ventricular Assist Device System, for example, is a pump that assists the.....In the last three years, one of the world's most sophisticated device companies developed..
http://www.fda.gov/ola/1997/devices.htm (score=74)

Regulating Medical Devices and Adaltis Labotech device
...The Labotech device is an automated device intended for use in performing controlled chemical reactions that are.....User facilities are required to report device-related deaths to FDA, and to report device.....The definition of device specifically includes articles intended for use in the diagnosis..
http://www.fda.gov/ola/2004/adaltis0518.html (score=74)

Make Sure the Medical Device You Choose is Designed for You
...Are there device characteristics that can affect its use?q Is the device simple to set up.....q Will you be able to understand and use the device?q Do you need to remember complex.....q Does the device have safety features to prevent it from harming your children or pets..
http://www.fda.gov/cdrh/humfac/you_choose_checklist.pdf (score=74)

HUMANITARIAN DEVICE EXEMPTION (HDE) REGULATION
...HUMANITARIAN DEVICE EXEMPTION (HDE) REGULATION QUESTIONS AND ANSWERS ..This document has.....HUMANITARIAN DEVICE EXEMPTION (HDE) REGULATION....FDA Home Page | CDRH Home Page | Search..
http://www.fda.gov/cdrh/ode/hdeqna.html (score=74)

Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation...
...87, including the proposed labeling for the device sufficient to describe the device, its intended use, and the directions.....Actual comparison of the new device performance to that of a previously cleared device is.....If the finished device does not meet the acceptance criteria and, thus, differs from the..
http://www.fda.gov/cdrh/oivd/guidance/1236.html (score=74)

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