510(k)s Final Decisions Rendered
...25-JUN-99 WILLIAM MERZ BUILDING 510(k) SUMMARY AVAILABLE FROM FDA MCGAW PARK, IL 60085.....MALAYSIA 43000 DEVICE: LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CO.....25-JUN-99 DAVIS, CA 95616 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOSE CALC, MODEL VS. 1.02..
http://www.fda.gov/cdrh/510k/sumjun99.html (score=100)

PMA Final Decisions Rendered for December 1995
...APPROVAL OF MINIMUM 12/13/95 DEVICE DOSE GAMMA CONFIGURATION OF WARSAW, IN IRRADIATION THE NEW.....APPROVAL OF MINIMUM 12/13/95 TOTAL KNEE SYSTEM DOSE GAMMA WARSAW, IN IRRADIATION 46581.....APPROVAL OF ETHYLENE 12/13/95 DEVICE OXIDE STERILIZATION CONFIGURATION OF WARSAW, IN FOR..
http://www.fda.gov/cdrh/pmadec95.html (score=100)

510(k)s Final Decisions Rendered
...31-AUG-00 SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANT HILL, CA 94523-3389.....23-AUG-00 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOSE 1 SCANDITRONIX.....25-AUG-00 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HP M2376A DEVICE LINK SYSTEM, MODEL..
http://www.fda.gov/cdrh/510k/sumaug00.html (score=100)

MDI and DPI Drug Products
...DPIs, the formulation, and the device with all of its parts including any protective.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation.....designs include pre-metered and device-metered DPIs, both of which can be driven by..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=39)

CDRH Fiscal Year 2000 Annual Report
...expertise in the particular device area, identify the issues related to the device, the.....fraction of the radiation dose common in medical diagnostic procedures, but has a.....calculated an average annual solar UV dose based on data from the Environmental Protection..
http://www.fda.gov/cdrh/annual/fy2000/annualreport-2000.pdf (score=32)

Document
...and the maximum content of tin, associated with the use of the device, in.. consensus.....1) No systemic dose- study, drawn from approximately 1,200.. rare instances, cause local.....controls for the existing class II device, the amount of vapor released. The.. majority of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/022002a.pdf (score=32)

...There is no valid scientific evidence demonstrating specific adverse responses or a dose.....A preamendments device that has been classified into class III may be marketed, by means.....Due to an inadvertent error, the preamendments device encapsulated amalgam alloy and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/022002a.htm (score=32)

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