Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule

Recent Additions In CDRH

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* Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability Text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* Draft Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence Text PDF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

Updated October 4, 2008

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH