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Surmodics Sublime Radial Access PTA Catheter Cleared

[ Price : $8.95]

FDA clears a Surmodics 510(k) for its Sublime Radial Access 0.014 Rapid Exchange percutaneous transluminal angioplasty dilatation ...

Info Collection on Extralabel Animal Drug Use

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection entitled Extralabel Drug Use for Animals 21 CFR 530.

DoJ Seeking $13 Billion for OxyContin Claims: Report

[ Price : $8.95]

Reuters reports that the Justice Department is asking for nearly $13 billion to resolve charges against Purdue Pharma and its Sack...

Life Spine Plateau-A Lumbar Spacer Cleared

[ Price : $8.95]

FDA clears a Life Spine 510(k) for the Plateau-A Ti Anterior Lumbar Spacer System, intended for use for anterior fusion procedures...

CME America Recalls BodyGuard Infusion Pump

[ Price : $8.95]

CME America recalls its BodyGuard Infusion Pump System due to infusion errors.

Siemens Somatom Mobile CT Scanner Cleared

[ Price : $8.95]

FDA clears a Siemens Healthineers 510(k) for the Somatom On.site, a mobile head computed tomography scanner.

AbbVie Ends Voyager Therapy Development Pact

[ Price : $8.95]

Voyager Therapeutics says AbbVie has ended two agreements under which Voyager was to research and develop treatments for Alzheimer...

Rare Disease Clinical Trial Networks

[ Price : $8.95]

Three industry and patient stakeholders express support for the creation of one or more rare disease clinical trial networks.

Combo Product Constituent Part Applicant Info Collection

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for Postmarketing Information Sharing Among Constitu...

Combo Products Office Pilots eSubmission Process

[ Price : $8.95]

Federal Register notice: FDA seeks applicants to participate in an Office of Combination Products voluntary pilot program to help ...