Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).
Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.
CDRH’s 2012 priorities include a strong focus on innovation and the device approval process, a strategic report shows.
House Democrats are urging the Committee on Energy and Commerce to hold hearings on whether the FDA and device industry are doing all they can to protect consumers from unsafe products.
The M-Vu Algorithm Engine is a software application designed to process digitized film images of the breast. The software analyzes the images and marks suspicious areas consistent with breast cancer for review by a radiologist. The results are displayed o
Labeling, Approval Order, and Summary of Safety and Effectiveness for M-Vu Algorithm Engine (P100005).
Labeling, Approval Order, and Summary of Safety and Effectiveness for MelaFind® (P090012).
ARNOLD, MD - Suspension Orthopaedic Solutions announced it has received FDA 510(k) clearance for two new products - its Distal Clavicle Fracture Fixation Systemâ„¢ and a new plate designed to address repair of mid-shaft clavicle fractures. The new Distal Clavicle Fracture Fixation System features...
Consumer Information on: ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Assay and ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA & #xae; Centaur and ...January 24, 2012 3:31 am | by U.S. Food & Drug Administration | News | Comments
ADVIA Centaur Anti-HBs2 (aHBs2) assay is a laboratory test used to detect antibodies associated with hepatitis B virus (HBV) infection.
Summary Information for: ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Assay and ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA & #xae; Centaur and ...January 24, 2012 3:30 am | by U.S. Food & Drug Administration | News | Comments
Labeling, Approval Order, and Summary of Safety and Effectiveness for ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA® Centaur and ADVIA® Centaur XP Systems (P100039).
A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report.
Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)January 20, 2012 1:30 pm | by U.S. Food & Drug Administration | News | Comments
The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML.
Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health HazardsJanuary 20, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments
Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.
Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial ContaminationJanuary 20, 2012 9:30 am | by U.S. Food & Drug Administration | News | Comments
Possibility of an adverse reaction or unknown drug-drug interaction.
The GORE TAG Thoracic Endoprosthesis is an artificial endovascular stent graft and is used to treat isolated lesions, excluding dissections, of the descending thoracic aorta during endovascular repair. Some of the complex isolated lesions include...
Labeling, Approval Order, and Summary of Safety and Effectiveness for GORE TAG Thoracic Endoprosthesis (P040043S040).
Sutton, MA â€“ Interstate Specialty Products, Inc., a manufacturer of high performance custom gaskets and provider of custom die-cutting services, recently received ISO 13485 certification for their quality management system. ISO 13485 is an international standard thatspecifies requirements...
LOS ANGELES/PRNewswire/ --Â Grifols, a global healthcare company and biopharmaceutical manufacturer based in Barcelona, Spain, announced that its U.S. diagnostic and hospital divisions have received ISO 13485:2003+AC:2009 certification, an international quality standard...
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate.
Surgical mesh manufacturers have until Feb. 3 to submit their plans to the FDA for conducting postmarket studies under Section 522 of the 1938 FD&C Act.
FDA-industry negotiations to reauthorize the Medical Device User Fee Act (MDUFA) went down to the wire last week, as CDRH seemed destined to miss a Jan. 15 due date for sending a commitment letter to Congress.
Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary ToxicityJanuary 13, 2012 7:31 am | by U.S. Food & Drug Administration | News | Comments
New Boxed Warning and Contraindication highlighting these risks added to product labeling.
Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass ParticlesJanuary 12, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments
Particulate matter in injections can be harmful when introduced into the bloodstream.
The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices.
Consumer Information on: Berlin Heart EXCOR & #xae; Pediatric Ventricular Assist Device (VAD) - H100004January 11, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments
The EXCOR® Pediatric VAD is a blood pump that vibrates rhythmically and is designed to assist patients who cannot pump enough blood with their own natural heart. The device can be used in patients who cannot effectively pump blood with their left and/or..