LDR, a total spine solution company, announced that it received FDA clearance on Feb. 2 to market its ROI-A™ implant as an anterior lumbar interbody fusion (ALIF) device.
FDA Approval
Covidien Receives FDA Clearance For New Pulse Oximeter With OxiMax SPD™ Alert
Covidien announced today that the United States Food and Drug Administration has issued a 510(k)marketing clearance for the Nellcor™ OxiMax™ N-600x™ pulse oximeter with OxiMax SPD™ alert.
NovaLign nabs FDA approval for bone fixation system
NovaLign Orthopedics Inc. can now market its first product, a bone fixation system, after it received clearance from the Food and Drug Administration.
Covidien Receives FDA Clearance for the Nellcor™ OxiMax™ N-600x™ Pulse Oximeter with OxiMax SPD™ Alert
Covidien, a leading global provider of healthcare products, today announced that the United States Food and Drug Administration has issued a 510(k)marketing clearance for the Nellcor™ OxiMax™ N-600x™ pulse oximeter with OxiMax SPD™ alert for adults.
St. Jude Medical Announces FDA Approval Of New Features In Remote Patient Care For Implantable Cardiac Devices
St. Jude Medical, Inc. announced U.S. Food and Drug Administration approval of the newest version of the Merlin.net™ Patient Care Network, a secure, Internet-based remote care system for patients with implanted medical devices.
FDA Approves SyntheMed’s REPEL-CV® Adhesion Barrier for Use in Pediatric Cardiac Surgery
SyntheMed, Inc., a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that the U.S. Food and Drug Administration has approved the Pre-market Approval application for REPEL-CV® Adhesion Barrier for use in pediatric cardiac surgery patients.
Stereotaxis Announces First Uses of the NAVISTAR® RMT THERMOCOOL® Catheter
Stereotaxis, Inc. announced today that clinicians at two centers in the United States have performed successful cardiac ablation procedures with the NAVISTAR® RMT THERMOCOOL® catheter since the announcement of its approval by the U.S. Food and Drug Administration on February 26.
SBi’s S.T.A.R. Total Ankle Replacement System Receives FDA Approvable Letter
Small Bone Innovations, Inc. (SBi) announced today that an ‘Approvable Letter’ has been received from the U.S. Food and Drug Administration (FDA) for the Scandinavian Total Ankle Replacement system (S.T.A.R. Ankle).
Transoma Medical Receives FDA Marketing Clearance For Sleuth AT™ Implantable Cardiac Monitoring System
Transoma Medical, manufacturer of Sleuth, the first wireless, automated implantable cardiac monitoring system has now received FDA marketing clearance on its second-generation product, Sleuth AT™ (Advanced Trending) Cardiac Monitoring System.
FDA Grants Marketing Approval to NAVISTAR® THERMOCOOL® Catheter for Atrial Fibrillation
NAVISTAR® THERMOCOOL® Catheter first and Only Ablation Catheter Approved for Treatment of Heart Rhythm Disorder That Affects Up to 5 Million People in the U.S.
Pioneer® Surgical Technology Receives 510(k) Clearance To Market FortrOss™, A Next Generation Bone Void Filler
Pioneer Surgical Technology, Inc. today announced the U.S. market release of their FortrOss bone graft substitute.
FDA Clearance for Jetstream™ Pathway PV™ Atherectomy System
Next-Generation Atherectomy Device Offers Minimally Invasive Treatment for Peripheral Artery Disease
Edwards Lifesciences Receives FDA Approval For PERIMOUNT Magna Mitral Heart Valve
Edwards will launch the PERIMOUNT Magna mitral valve in the United States immediately.