Durable ePTFE Endoprosthesis Designed for Endovascular Repair of the Descending Thoracic Aorta Provides Conformability without Compromise
FDA Approval
Ethicon Endo-Surgery Receives 510(k) Clearance for New ENSEAL® G2 Curved and Straight Tissue Sealers Line — Broadest Range of Advanced Bipolar Tissue Sealers Available for Open and Minimally Invasive Surgery
Ethicon Endo-Surgery, Inc. has announced U.S. FDA 510(k) clearance of its innovative ENSEAL® G2 Curved and Straight Tissue Sealers
Early Clinical Evaluation Of Medical Devices In USA: FDA Issues Draft Guidance Document
Draft Guidance for Industry and Food and Drug Administration Staff – Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
Transcatheter Cardiovascular Therapeutics conference 2011: Live link of UK case highlights FDA’s caution on Sapien Aortic Valve PMA.
Update from TCT2011 sourced from an article by Medical Device Daily
Cordis Empira PTCA Catheters get 510(k) approval for Coronary Artery Disease
Cordis Corporation has announced EMPIRA™ and EMPIRA™ NC RX PTCA Dilatation Catheters have received 510(k) regulatory clearance for the treatment of coronary artery disease.
Abbott Receives U.S. FDA Approval for Next-Generation XIENCE PRIME™ Drug Eluting Stent
Following CE Mark approval in 2009, Abbott now gains FDA approval for Xience Prime Drug Eluting Stent
ArthroCare(R) Receives FDA Clearance for SpeedLock(R) Knotless Fixation Device
ArthroCare Corp. has announced that it has received US FDA clearance for its SpeedLock(R) Knotless Fixation Device
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Medtronic Announces 510(k) Clearance for the Aquamantys®3 System with Combined Hemostatic Sealing and Cutting Functionality
Medtronic, Inc. has announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its Aquamantys®3 System as well as the new 8.2L Bipolar Sealer with Cutting and 6.0 Bipolar Sealer hand pieces.
Unisense FertiliTech’s EmbryoScope® Receives FDA 510(k) Clearance for day 5 culture of human embryos in IVF
Danish company Unisense Fertilitech has announced the gaining of FDA approval for its EmbryoScope® for clinical use in the United States.
New Duodenal Stent gains FDA approval: Provides Relief to Patients with Advanced Small Intestine Cancer
Cook Medical has announced that its Evolution® Duodenal Controlled-Release Stent was recently granted 510(k) clearance by the Food & Drug Administration (FDA)
Smith & Nephew Takes Single Injection PMA to Next Stage
Smith & Nephew Biologics & Spine is proceeding to the next stage in the approval process for the U.S. launch of DUROLANE® Single Injection, Stabilized Hyaluronic Acid.
CryoLife Receives FDA 510(k) Clearance For SynerGraft® Processed Human Cardiac Patch Material
CryoLife, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CryoPatch(®) SG pulmonary human cardiac patch.
Life Spine® Announces FDA Clearance Of FS3™ Minimally Invasive Spinal System
Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the FS3 Minimally Invasive Spinal System.
St. Jude Medical Announces FDA Approval of the Cool Point Irrigation Pump
St. Jude Medical, Inc. today announced U.S. Food and Drug Administration (FDA) approval of its Cool Point™ Irrigation Pump.
EarlySense’s EverOn™ System Receives FDA Clearance and CE Mark Certification
EarlySense announced today that its EverOn contact-free patient supervision system has been cleared for marketing by the U.S. Food and Drug Administration and has received a CE Mark certification from KEMA, a Dutch notified body.