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Zold - Medical Dev. & Diag. - FDA - CDRH - General Updates
Neoprobe Corporation (NEOP) Files Response to FDA Review Letter of RIGScan(TM) Biologic License Application 10/21/2010
CDRH Updates: TAXUS(R) Liberte(TM) Long Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems) - P060008/S011 8/4/2009
CDRH Updates: Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff 8/4/2009
CDRH Updates: Federal Register: Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability 8/4/2009
CDRH Updates: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting 7/13/2009
CDRH Updates: Ongoing Safety Review of Arthroscopic Shavers 7/8/2009
CDRH Updates: CDRH White Oak Move 7/8/2009
CDRH Updates: Center for Devices and Radiological Health Forum for International Medical Device Regulatory Authorities 7/8/2009
CDRH Updates: Information on Premarket Approval Applications: TAXUS(R) Liberté(R) Atom(TM) Paclitaxel-Eluting Coronary Stent System 6/4/2009
CDRH Updates: April 2009 PMA Approvals 6/4/2009
CDRH Updates: Summary Information for ARCHITECT(R) CORE Reagent Kit, Calibrator and Controls 6/4/2009
CDRH Updates: Consumer Information on: REPEL-CV(R) Bioresorbable Adhesion Barrier - P070005 5/11/2009
CDRH Updates: Biosite Incorporated (BSTE) Class I Medical Device Recall: Triage Cardiac Panel 5/11/2009
CDRH Updates: Federal Register: Implementation of Post-Approval Studies for Medical Devices; Public Workshop 5/11/2009
Disetronic Medical Systems Announces Recall of the ACCU-CHEK(R) Spirit Insulin Pump Due to Button Failures 5/1/2009
CDRH Updates: Consumer Information on: ARCHITECT(R) CORE Reagent Kit, Calibrator and Controls - P080023 4/17/2009
CDRH Updates: Draft Guidance for Industry and FDA Staff: Investigational Device Exemption Guidance for Retinal Prostheses 4/17/2009
CDRH Updates: Consumer Information on: Medtronic(R) Attain Ability(TM) Model 4196 Lead - P080006 4/17/2009
CDRH Updates: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting 4/8/2009
CDRH Updates: 510(k) Final Decisions for March 2009 4/8/2009
CDRH Updates: Required Submission of Safety and Effectiveness Information for Certain Class III Devices 4/8/2009
CDRH Updates: Ophthalmic Devices Panel 3/13/2009
CDRH Updates: Draft Guidance for Industry and FDA Staff 3/13/2009
CDRH Updates: FDA Warns About Risk of Wearing Medicated Patches During MRIs 3/5/2009
CDRH Updates: 510(k)s Final Decisions Rendered for February 2009 3/5/2009
CDRH Update: National Registry on Safety & Atrial Fibrillation Ablation: An Incubator Thinktank 2/25/2009
CDRH Updates: PMA Final Decisions Rendered for January 2009 2/25/2009
CDRH Updates: Guidance for Industry and FDA Staff: Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket 510(k) Submissions 1/27/2009
CDRH: Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex 1/6/2009
CDRH: Draft Guidance for Industry and FDA Staff; Assay Migration Studies for In Vitro Diagnostic Devices; Availability 1/6/2009
CDRH Updates: Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document 12/23/2008
CDRH: Anesthesiology and Respiratory Therapy Devices Panel 12/9/2008
MedWatch: Thoratec Corporation (THOR) Issues Worldwide Medical Device Correction of HeartMate II(R) Left Ventricular Assist System 10/28/2008
CDRH Updates: Summary Information for: TAXUS(TM) Express2(TM) Paclitaxel-Eluting Coronary Stent System 10/14/2008
CDRH Updates: Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting 10/14/2008
CDRH: Class I Medical Device Recall: Nebion, LLC HLX-8 Magnetic Resonance Device 10/3/2008
CDRH Updates: Consumer Information on: Akreos(R) Posterior Chamber Intraocular Lens 10/2/2008
CDRH Updates: New Device Approval: COBAS TaqMan HBV Test For Use With The High Pure System 10/2/2008
CDRH Updates: Hoya iSpheric (TM) Model YA-60BB Intraocular Lens 10/2/2008
CDRH Update: Registration and Listing Device Establishment Registration and Listing for FY2009 Now Available 10/1/2008
CDRH Updates: Electronic Copies for Pre-Market Submissions General Information 9/30/2008
CDRH Updates: Summary Information for: NexGen(R) LPS-Flex Mobile Bearing and LPS-Mobile Bearing Knees 9/26/2008
Public Health Notification: Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status 9/24/2008
CDRH Update: PMA Final Decisions Rendered for July 2008 8/25/2008
CDRH Updates: Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment 8/21/2008
CDRH Updates: New Device Approval T-SPOT.TB Lab Test Kit)T-SPOT(R) 8/20/2008
CDRH Update: Guidance for Industry: Medical Device Tracking; Guidance for Industry and FDA Staff 8/15/2008
CDRH Update: Class I Medical Device Recall: Boston Scientific Corporation (BSX) NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System 8/14/2008
CDRH Update: Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff 8/14/2008
CDRH Update: FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008 8/14/2008
CDRH Update: Orthopaedic and Rehabilitation Devices Panel Meeting 8/12/2008
CDRH Update: Guidance for Industry and FDA Staff: Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter 8/7/2008
CDRH Update:Federal Register: Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications 8/7/2008
CDRH Update: Federal Register: Humanitarian Device Exemption Regulation: Draft Guidance for Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Questions and Answers 8/5/2008
CDRH Update Summary of 510(k) Final Decisions - July 2008 8/5/2008
CDRH Updates: Summary Information for: ELA Ovatio CRT-D System 7/30/2008
CDHR Updates: Gastroenterology and Urology Devices Panel Agenda, Draft Roster, Final Roster, Briefing, Questions, Transcript 7/29/2008
CDRH Update: Video Added - FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, March 18-19, 2008 7/25/2008
CDRH Updates: Summary Information for: Access® Hybritech® PSA reagents on the Access® Immunoassay Systems 7/24/2008



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