FDA Approval
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FDA approves Carestream’s bone suppression software
The Food and Drug Administration has given Carestream Health Inc. approval to sell its newest image acquisition software with an…
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Biologics
BioStructures, LLC Receives 510(k) Clearance for Innovative Bioactive Bone Graft Putty and Bone Graft Extender.
NEWPORT BEACH, Calif., Feb. 18, 2014 /PRNewswire/ — BioStructures, LLC, a privately held orthobiologics company, today announced that the United States Food…
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LDR Receives First FDA Approval for Two-Level Cervical Disc Replacement
AUSTIN, Texas–(BUSINESS WIRE)– LDR, a privately held medical device company offering exclusive spinal implant technologies for both non-fusion and fusion…
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LDR Receives FDA Approval for One Level Mobi-C
LDR Receives FDA Approval for the Mobi-C Cervical Disc for One-Level Use First mobile-bearing, bone-sparing cervical disc approved in the…
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Hologic Gets FDA OK on Femur X-ray Exam
Hologic Inc. received clearance by the U.S. Food and Drug Administration for its Single Energy Femur Exam on its x-ray…
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Blue Belt Technologies Announces US FDA Clearance to Market its STRIDE Unicondylar Knee System
PITTSBURGH & MINNEAPOLIS–(BUSINESS WIRE)–Blue Belt Technologies, Inc., an innovative medical technology company commercializing robotic-assisted solutions for orthopedic surgery, today announced…
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Uncategorized
Ascendx Spine™ Receives FDA 510(k) Clearance for its Ascendx VCF Repair System Designed for the Treatment of Vertebral Compression Fractures (VCFs)
December 18, 2012 01:48 PM Eastern Time WINTER PARK, Fla.–(BUSINESS WIRE)–Ascendx Spine™, Inc., (www.ascendxspine.com) has received FDA 510(k) clearance for its Ascendx VCF Repair System.…
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Spine
LDR Holding receives FDA approval
Medical device maker LDR Holding Corp.has received clearance from federal regulators to market another spinal product. The Austin-based company disclosed Tuesday…
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X-spine gets FDA approval for fusion system
X-spine Systems Inc., a spinal disease treatment device manufacturer, this week received FDA clearance for an interspinous fusion system to…
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Covidien Announces DuraSeal™ Exact Spine Sealant Receives FDA Approval
MANSFIELD, Mass.–(BUSINESS WIRE)–Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that its DuraSeal™ Exact spine sealant…
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DiFUSION Technologies Receives 510(k) Clearance of Xiphos™ Interbody Implants for Spinal Fusion
AUSTIN, Texas–(BUSINESS WIRE)–DiFUSION Technologies Inc., a medical device company focused on the development and commercialization of its proprietary CleanFUZE™ anti-microbial…
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Centinel Spine Receives 510K Clearance for STALIF MIDLINE™
NEW YORK–(BUSINESS WIRE)–Centinel Spine, Inc. (Centinel), a leader in developing Integrated Interbody Fusion™ devices, announced today that it has received…
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Ascension Orthopedics Receives FDA Approval for TITAN™ Modular Total Shoulder System
AUSTIN, Texas, Sept. 2 /PRNewswire/ — Ascension Orthopedics, Inc., the world leader in PyroCarbon orthopedic devices, announces FDA approval to market the…
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Ulrich Medical Obtains 510(k) Approval
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090861.pdf
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When The FDA Comes Knocking, Is Your Company Prepared?
It’s become clear in the first four months of this year that the FDA is ratcheting up its efforts to…
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