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Class I Medical Device Recall: Roche Diagnostics Operations, ACCU-CHEK Performa Strip

June 20, 2011 5:31 am | by U.S. Food & Drug Administration | News | Comments

This product was NOT distributed in the U.S. The product was only distributed in France on October 5, 2010.

Minutes from Negotiation Meeting on MDUFA III Reauthorization: June 1, 2011

June 20, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

To discuss Industry?s proposals for the next reauthorization, as well as present data on workload issues and discuss additional FDA proposals.

Boston Scientific Innova Self-Expanding Stent System: Recall - Failure to Deploy(2)

June 17, 2011 11:31 am | by U.S. Food & Drug Administration | News | Comments

Failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent.

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Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events

June 16, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Results of a randomized, double-blind, placebo-controlled clinical trial of 700 smokers reviewed.

Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin-resistant Staphylococc...

June 15, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

FDA is issuing this draft guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of methicillin-resistant...

Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall – Catheter Tip Can Break Inside of the Patient

June 14, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of embolization causing tissue and blood vessel injury, heart attack or other serious events.

Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall – Shuts Off Without Warning

June 14, 2011 9:31 am | by U.S. Food & Drug Administration | News | Comments

Consequences may include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events.

Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall – Fragments of Adhesive and Plastic in the Cannula Tip May Embolize

June 14, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of arterial injury, hemorrhaging, or other serious events.

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Class I Medical Device Recall: Terumo Coronary Ostia Cannula 10, 12, 14 Fr

June 14, 2011 8:32 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Foreign fragments of adhesive and plastic in the cannula tip may embolize causing arterial injury, hemorrhaging or other serious events requiring unplanned surgery.

Class I Medical Device Recall: Maquet Datascope Corp. Intra-Aortic Balloon Pumps

June 14, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: A defective fan in the power supply may cause overheating and shut down the device without visible or audible alarms. Consequences of unanticipated interruption of therapy may include the inability to decrease already-present ischemia..

510(k) Final Decisions - May 2011

June 9, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

This website has been translated to Spanish from English, and is updated often. It is possible that some links will connect you to content only available in English or some of the words on the page will appear in English until translation has been completed (usually within 24 hours). We appre

Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May ...

June 7, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Inhalation of the plastic strands may cause respiratory compromise, which could result in serious illness or death.

Class I Medical Device Recall: Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate)

June 6, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could...

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PMA Final Decisions for April 2011

June 6, 2011 10:31 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for April 2011.

Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products

June 3, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments

Potential for serious anaphylactic reaction in patients with known hypersensitivity to beta-lactam or penicillin products.

Summary Information for: XIENCE nano? Everolimus Eluting Coronary Stent System

June 3, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for XIENCE nano? Everolimus Eluting Coronary Stent System (P070015S054).

Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication

June 2, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer.

FDA Safety Communication: Breast Cancer Screening - Thermography is Not an Alternative to Mammography

June 2, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

The FDA is issuing this communication to alert the public, including women and health care providers, that thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. The FDA is not aware of any

Letter To Foreign and Domestic Medical Device and Component Establishments That May Be Affected by the March 2011 Japan Earthquake and Tsunami

June 1, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Japan is a critical participant in the global medical device market. As you know, on March 11, 2011, a massive earthquake and tsunami occurred near the northeastern coast of Japan, followed by various aftershocks, causing extensive damage to this region..

Information on Drugs of Abuse Tests (Updated)

June 1, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

FDA regulates and reviews drugs of abuse tests before they can be sold to consumers or healthcare professional in the United States. In its review, the FDA evaluates the design and performance of tests and sample collection systems to help ensure that...

FDA Considers Reference Method for Influenza Diagnostics

May 27, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

CDRH is seeking a contractor to study rapid molecular diagnostic methods for detecting influenza, as it considers using them as faster and more accurate reference methods for premarket evaluation of influenza diagnostics.

Industry Advises No FDA Regulation for Some mHealth Devices

May 27, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

An industry group is advising the FDA to not regulate certain mobile health (mHealth) products, which can include medical smart phone applications, because their “social benefit” outweighs their inherent low risk.

Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall - Incorrect Electrolyte Results

May 23, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments

Errors may be the result of ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, and instrument maintenance.

Pentrexyl Forte Natural: Recall - Misleading Packaging

May 23, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments

Dietary supplement product packaging may cause it to be confused with an antibiotic product.

Class I Medical Device Recall: Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell

May 23, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: There may be ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments (ion selective electrolyte flow cell) which may cause incorrect...

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