October 3, 2008 |
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Class I Medical Device Recall: Nebion, LLC HLX-8 Magnetic Resonance Device |
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October 2, 2008 |
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Consumer Information on: Akreos® Posterior Chamber Intraocular Lens - P060022 |
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Consumer Information on: COBAS TaqMan HBV Test For Use With The High Pure System - P050028 |
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Consumer Information on: Hoya iSpheric™ Model YA-60BB Intraocular Lens - P080004 |
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October 1, 2008 |
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Class I Medical Device Recall: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit |
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Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Written Comments |
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Registration and Listing (Device Establishment Registration and Listing for FY2009 Now Available) |
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September 29, 2008 |
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Electronic Copies for Pre-Market Submissions (Updated 09/08) |
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September 26, 2008 |
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Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications |
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Summary Information for: NexGen® LPS-Flex Mobile Bearing and LPS-Mobile Bearing Knees |
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September 24, 2008 |
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Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program |
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FDA Public Health Notification: Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status |
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September 22, 2008 |
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Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)] |
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PMA Final Decisions for August 2008 |
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September 19, 2008 |
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Summary Information for: Akreos™ Posterior Chamber Intraocular Lens |
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Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability |
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September 18, 2008 |
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Draft Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence |
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Maturity Health Matters: FDA Health News for Older Adults and Their Caregivers (Fall 2008 Issue) |
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September 17, 2008 |
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Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date |
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September 16, 2008 |
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Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers |
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September 12, 2008 |
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Federal Register: Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket |
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September 11, 2008 |
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Federal Register: Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of Comment Period |
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Summary Information for: COBAS® TaqMan® HBV Test For Use With the High Pure System |
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FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008 (Final Agenda Now Available) |
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Federal Register: General and Plastic Surgery Devices: Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period |
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Class I Medical Device Recall: Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs) |
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Federal Register: Public Advisory Panels or Committees: Request for Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives |
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September 9, 2008 |
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Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 020 |
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September 8, 2008 |
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Federal Register: FDA Clinical Trial Requirements Regulations, Compliance, and Good Clinical Practice Conference; Public Workshop |
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