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Category : Medical Device

FDA Exercises Poor Oversight Over TMJ Device Manufacturers and Patients With TMJ Implants Suffer the Painful Consequences

More than 10 million Americans suffer from a condition known temporomandibular joint disorder, or TMJ, which causes varying levels of...

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FDA Recalls Sigma Spectrum Infusion Pump Model 35700

FDA notified healthcare professionals of the class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700, which is used...

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Avoidable Medical Errors Such as Pressure Ulcers and Postoperative Infections Cost U.S. Economy $19.5 Billion in 2008

A study released earlier this year by the the Society of Actuaries (SOA) estimated that measurable medical errors cost the...

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Dental Handpieces May Cause Patient Burns

Late last month, the U.S. Food and Drug Administration issued an alert to healthcare professionals and dental organizations concerning patient burns...

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Medtronic Voluntarily Recalls Infusion Sets Used to Deliver Insulin from an Insulin Pump to a Diabetes Patient

Reports on Medco's recall of infusion sets used with insulin pumps

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Medtronic Recalls Kappa and Sigma Pacemakers With Wiring Problems

Notifies readers of the Class 1 recall of Medtronic pacemakers

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Congress Considering Legislation to Eliminate Manufacturers’ Blanket Immunity From Lawsuits Over Faulty Medical Devices Preapproved by FDA

Provides status update on Medical Devices Safety Act of 2009 with link to article on pros and cons.

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FDA Video Series Covers Recalls and Safety Alerts for Prescription Drugs and Medical Devices

The FDA’s Patient Safety News (PSN) is a series of monthly video news shows addressing significant approvals, recalls, and safety...

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Supreme Court Limits Lawsuits Over Medical Devices

The Supreme Court today issued their decision in Riegel v. Medtronic, Inc.  At issue before the Court was whether the...

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FDA Announces Class 1 Recall of Medtronic Sprint Fidelis® Defibrillator Leads

On October 17, 2007, the FDA issued a Class 1 recall of Medtronic’s Sprint Fidelis® Defibrillator Leads, model numbers 6930,...

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