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FDA Allows Marketing of Kidney Injury Test

[ Price : $8.95]

FDA approves an Astute Medical de novo petition to allow marketing of the NephroCheck test, a lab test designed to help determine ...

FDA Clears Esaote Ultrasound System

[ Price : $8.95]

FDA clears an Esaote North America 510(k) for its MyLab Six ultrasound system.

Customed Recalls Surgical Packs Due to Sterility Concerns

[ Price : $8.95]

Customed recalls multiple surgical packs manufactured between 1/2009 and 5/2014 due to sterility concerns.

Docket Available on Duchenne Muscular Dystrophy

[ Price : $8.95]

Federal Register Notice: FDA establishes a public docket to discuss issues on developing drugs for Duchenne muscular dystrophy.

Advisors Support OTC Antiseptic Standards

[ Price : $8.95]

Members of the FDA Nonprescription Drugs Advisory Committee unanimously vote to support standards proposed by the agency to demons...

FDA Approves Mercks Keytruda for Melanoma

[ Price : $8.95]

FDA grants accelerated approval to Merks Keytrada for treating patients with advanced or unresectable melanoma who are no longer r...

Wheelchair Reclassification Bid Needs More Info

[ Price : $8.95]

FDA asks Canadas Adaptive Engineering for more information to support its petition request for a Class 2 exemption for its portabl...

Cook Class 1 Recall of CloverSnare Vascular Retriever

[ Price : $8.95]

Cook recalls its CloverSnare 4-Loop Vascular Retrieval Snare, which is used to manipulate and retrieve items in the cardiovascular...

Cerapedics PMA for i-Factor Bone Graft

[ Price : $8.95]

Cerapedics files a PMA for its i-Factor Peptide Enhanced Bone Graft, intended for use as an alternative to autograft harvesting in...

Suir Pharma Antibiotic Facility Passes GMP Inspection

[ Price : $8.95]

FDA completes a GMP inspection of Suir Pharmas antibiotic plant in Ireland, which resulted in no Form 483 observations.