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).
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...
Labeling, Approval Order, and Summary of Safety and Effectiveness for Breast Companion® Software System (P100007).
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...
Labeling, Approval Order, and Summary of Safety and Effectiveness for Ovation Abdominal Stent Graft System (H100008).
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..
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 - AEDsMarch 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 InjuryMarch 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.
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...
Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator: Class I Recall â€“ Cable May Cause an Electrical Shortage That can Cause Ventilators to Shutdown UnexpectedlyFebruary 28, 2012 10:31 am | by U.S. Food & Drug Administration | News | Comments
Customers should stop using the alarm cable
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 RegimenFebruary 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.
Proposed Sunshine Act provisions for documenting devicemaker payments to physicians need more context and clarity, industry members say.
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 PatientsFebruary 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 CircuitFebruary 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.
Reports of dosing syringe flow restrictor being pushed into the bottle when inserting the syringe.
Updates to sorbent hemoperfusion system, cardiovascular permanent pacemaker electrode, CES, external pacemaker pulse generator, implantable pacemaker pulse generator, pacemaker programmers
Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious InjuriesFebruary 16, 2012 10:31 am | by U.S. Food & Drug Administration | News | Comments
Brush head may break off in the user's mouth or near the face, causing cuts to the mouth and gums, chipped or broken teeth, swallowing and choking on the broken pieces, and injuries to the face and eyes.
Public Workshop - Design and Methodology for Postmarket Surveillance Studies under Section 522 of the Federal Food, Drug and Cosmetic Act, March 7, 2012February 16, 2012 5:32 am | by U.S. Food & Drug Administration | News | Comments
This workshop is open to all interested parties, including professionals in the scientific community interested in advancing the infrastructure and methodology for postmarket surveillance studies. The purpose of the workshop is to provide a forum for...
FDA Safety Communication: Choking Hazard and Serious Injuries with the Spinbrush line of Powered ToothbrushesFebruary 16, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments
The FDA is aware of reports of serious injuries and potential hazards associated with the use of the Spinbrush. These reports indicated that while turned on, the brush head has either ?popped off? or broken off in the user?s mouth or near the face...
The counterfeit version of Avastin does not contain the medicine's active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.
Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy: Class I Recall - Humidifier Lids Fail to Pop Off at the Intended PressureFebruary 14, 2012 4:31 am | by U.S. Food & Drug Administration | News | Comments
The humidifier can leak and can potentially interrupt the flow of supplemental oxygen to the patient.