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Class I Medical Device Recall: Acclarent Inspira AIR Balloon Dilation System, size 18X40mm.

March 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Acclarent identified the potential for the balloon to not deflate or to deflate slowly, which could result in airway obstruction until the balloon is deflated or removed. Prolonged obstruction of the airway may prevent adequate blood...

Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall - Potential For Balloon To Not Deflate Or To Deflate To Slowly

March 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient

Synthes Slapped With Wrongful Deaths Suit, FDA Warning Letter

March 9, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials.

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OIG Finds No Basis to Prosecute & #8216;FDA Nine & #8217; Over Personal Emails

March 9, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

After consulting with Justice Department prosecutors, the HHS Office of Inspector General (OIG) has found nothing to substantiate the FDA’s claim that it began monitoring nine employees’ emails only after hearing that confidential industry information had been leaked to the...

Gerber Good Start Gentle Powdered Infant Formula: Recall - Off-Odor

March 9, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

Reports of gastrointestinal complaints.

Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Norovirus Serological Reagents

March 8, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

This special controls guidance document was developed to support the classification into class II (special controls) of norovirus serological reagents. These devices detect norovirus antigens in human fecal specimens as an aid in the diagnosis of...

Summary Information for: ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems)

March 7, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems) (P100023S015).

Summary Information for: Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Re...

March 7, 2012 4:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity) (P110013).

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Consumer Information on: Breast Companion & #xae; Software System - P100007

March 6, 2012 7:32 am | by U.S. Food & Drug Administration | News | Comments

The Breast Companion® Software System is a computer-aided report-generating system intended to improve the ACR BI-RADS® (American College of Radiology, Breast Imaging Reporting and Data System) assessment of ultrasound images of lesions of the...

Summary Information for: Breast Companion & #xae; Software System

March 6, 2012 7:32 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Breast Companion® Software System (P100007).

Houston Medical Robotics, Inc. Receives FDA 510(k) Clearance for Euclid Tier 1 Mini Access System

March 6, 2012 4:48 am | News | Comments

Houston Medical Robotics, Inc. announces that it has received U.S. Food and Drug Administration 510(k) clearance to market the Euclidâ„¢ Tier 1 Mini Access System. The Euclidâ„¢ Tier 1 Mini Access System is a portable, hand-held device that integrates commercially available...

Summary Information for: Ovation Abdominal Stent Graft System

March 5, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Ovation Abdominal Stent Graft System (H100008).

Consumer Information on: OVATION Abdominal Stent Graft System - H100008

March 5, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

The OVATION abdominal stent graft system is used to treat abdominal aortic aneurysms during endovascular repair (EVAR). An aneurysm is a diseased, bulging, weak section of an artery wall; in this case the aorta. The main portion of the OVATION abdominal..

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Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Compo...

March 2, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Unexpected component failure may lead to AEDs not delivering defibrillation therapy, causing serious adverse health consequences, including death.

Class I Medical Device Recall: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators - AEDs

March 2, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

The affected AEDs contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy causing serious adverse health consequences

Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction Increases Risk of Muscle Injury

March 1, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk of myopathy, kidney damage, and kidney failure, which can be fatal.

Safety tips for intense pulsed light therapy

March 1, 2012 4:31 am | by U.S. Food & Drug Administration | News | Comments

Article originally published in Nursing2012, February issue. DEVICE SAFETY INTENSE PULSED LIGHT (IPL) therapy is indicated for use in surgical, aesthetic, and cosmetic applications. IPLs use flashlamps, computercontrolled power supplies, and bandpass...

Statin Drugs - Drug Safety Communication: Class Labeling Change

February 28, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

New adverse event and liver enzyme monitoring information in statin labels and updated drug interactions information in lovastatin label.

Radiological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (April 11-12, 2012)

February 28, 2012 3:31 am | by U.S. Food & Drug Administration | News | Comments

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Norgestimate and Ethinyl Estradiol Tablets: Recall - Packaging Error, Potential for Incorrect Dosing Regimen

February 27, 2012 3:30 am | by U.S. Food & Drug Administration | News | Comments

Women may be left without adequate contraception, and at risk for unintended pregnancy.

Industry to CMS: Accuracy, Clarity of Sunshine Act Provisions Needed

February 24, 2012 1:30 pm | by U.S. Food & Drug Administration | News | Comments

Proposed Sunshine Act provisions for documenting devicemaker payments to physicians need more context and clarity, industry members say.

J & #38;J Taps Devices Unit Head to Replace Beleaguered CEO

February 24, 2012 1:30 pm | by U.S. Food & Drug Administration | News | Comments

Johnson & Johnson’s (J&J) upcoming CEO switch, from Bill Weldon to devices business head Alex Gorsky, could signal the company’s confidence in its ongoing relaunch of McNeil Consumer Products, an analyst says.

Nemschoff Chairs Perinatal Pediatric Hospital Bed (Bassinet): Class 1 Recall - Risk of Injury to Patients

February 24, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

Doors and drawers may inadvertently open while bassinet is in motion; product may be difficult to maneuver due to it swivel caster configuration.

CareFusion Cortical Stimulator Control Unit: Class 1 Recall - Software Malfunction and Short Circuit

February 23, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

Affects device and software that aids in the identification and mapping of areas of the brain.

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