11 hours ago | News
During packaging and labeling, tablets from one product type may have carried over into packaging of another product.
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18 hours ago | News
Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.
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Feb 2 | News
Labeling, Approval Order, and Summary of Safety and Effectiveness for Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator (P110016).
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Feb 2 | News
The Therapy Cool Path Duo? Ablation Catheter or the Safire BLU Duo? Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia2) called typical atrial..
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Feb 1 | News
RESEARCH
TRIANGLE PARK, N.C.--(BUSINESS WIRE)--As
the industry awaits the release of the delayed Sunshine Act guidelines,
pharmaceutical and medical device companies are benefiting from the extra time
by reviewing current physician payment reporting structures...
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Feb 1 | News
The FDA and representatives from the medical device industry
have reached an agreement in principle on proposed recommendations for the
third reauthorization of a medical device user fee program.
The recommendations would authorize the FDA to collect $595 million
in user fees...
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Feb 1 | News
Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.
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Jan 31 | News
Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).
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Jan 30 | News
Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.
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Jan 27 | News
CDRH’s 2012 priorities include a strong focus on innovation and the device approval process, a strategic report shows.
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Jan 27 | News
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.
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Jan 27 | News
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
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Jan 27 | News
Labeling, Approval Order, and Summary of Safety and Effectiveness for M-Vu Algorithm Engine (P100005).
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Jan 25 | News
Labeling, Approval Order, and Summary of Safety and Effectiveness for MelaFind® (P090012).
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Jan 25 | News
ARNOLD, MD - Suspension Orthopaedic Solutions announced it
has received FDA 510(k) clearance for two new products - its Distal Clavicle
Fracture Fixation System™ and a new plate designed to address repair of
mid-shaft clavicle fractures.
The new Distal Clavicle Fracture Fixation System features...
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Jan 24 | News
ADVIA Centaur Anti-HBs2 (aHBs2) assay is a laboratory test used to detect antibodies associated with hepatitis B virus (HBV) infection.
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Jan 24 | News
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).
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