Medical Devices

The manufacturing, repackaging, re-labeling and importation of medical devices is regulated by the Center for Devices and Radiological Health (CDRH), a department of the Federal Food and Drug Administration (FDA). All medical devices sold in the United States are classified according to the level of precision required to operate the device safely and effectively. Reports on devices which have malfunctioned or caused death or serious injury are collected by the CDRH and stored in the Medical Device Reporting (MDR) database and the Manufacturer and User Facility Device Experience (MAUDE) database.


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Medical Devices and Products Recalls

At least weekly the Food and Drug Administration (FDA) issues health warnings and recall notices to the public. A recall is a method of removing or correcting medical products that are in... read more

Medical Devices -- An Overview

The Federal Food and Drug Administration (FDA)`s Center for Devices and Radiological Health (CDRH) is responsible for regulating companies/firms who manufacture, repackage, re-label, and/or import... read more

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Jury Verdicts Related to Medical Devices

______ VERDICT - PRODUCTS LIABILITY - MANUFACTURER OF ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTRA) ALLEGEDLY FAILS TO PERFORM ADEQUATE TESTING ON PRODUCT TO DETERMINE SUITABILITY FOR USE BY GENERAL SURGEON - ALLEGED FAILURE TO PROVIDE ADEQUATE WARNINGS REGARDING COMPLICATIONS ASSOCIATED WITH USE OF THIS PRODUCT.

______ VERDICT INCLUDING $20,000,000 PUNITIVE AWARD - PRODUCTS LIABILITY - DEFECTIVELY DESIGNED SILICONE BREAST IMPLANTS - LEAKAGE OF SILICONE - SYSTEMIC HEALTH CONSEQUENCES - PLAINTIFF SUFFERS SILICONE-INDUCED MIXED CONNECTIVE TISSUE DISEASE.

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FDA Information Related to Medical Devices

CDER Mailing Lists

Redirect Page

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MSN Newsfeeds Related to Medical Devices

Ingen Technologies Brings Oxyview(R) to Asia Through Major Medical ...

Solos Endoscopy, Inc. Vice President of Sales Featured in Audio ...

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News Articles Related to Medical Devices

Healthy Monday: MRI-friendly pacemaker is being tested at Northeast Georgia Medical Center

Sunday Business Post | Irish Business News

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Useful Web Sites Related to Medical Devices

Anapol Schwartz, Medical Device Attorneys

Burg Simpson, Faulty Medical Devices Attorneys

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Wikipedia Entries Related to Medical Devices

Medical device

Medical equipment

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Books Related to Medical Devices

Technology sourcing in the medical devices industry: The role of technology characteristics and organizational context : (Dissertation)

Acoustic microscopy of medical devices.(MPMD) : An article from: Advanced Materials & Processes

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