510k
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Hospitals
Trice Medical Receives FDA 510(K) Clearance for mi-eye 2
KING OF PRUSSIA, Pa., Oct. 6, 2016 — (Healthcare Sales & Marketing Network) — Trice Medical announced today that it…
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Hospitals
Meditech Spine Receives FDA Clearance for the CURE Anterior Cervical Plate System
ATLANTA, GA (PRWEB) SEPTEMBER 15, 2016 Meditech Spine has received the US Federal Drug Administration (FDA) 510(k) clearance to market the…
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Hospitals
Carestream’s OnSight 3D Extremity System Receives FDA 510(k) Clearance
September 08, 2016 08:30 AM Eastern Daylight Time ROCHESTER, N.Y.–(BUSINESS WIRE)–The CARESTREAM OnSight 3D Extremity System that uses cone beam…
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Hospitals
Additive Orthopaedics Announces the 510(k) Clearance of Their 3D Printed Osteotomy Wedge System for the Global Extremities Market
LITTLE SILVER, N.J., Sept. 8, 2016 /PRNewswire/ — Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that is…
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Hospitals
Spinal Elements® Receives 510(k) Clearance for Interspinous Process Device
CARLSBAD, CA (PRWEB) AUGUST 17, 2016 Spinal Elements, a spine technology company, announced that they have received 510(k) clearance from…
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Hospitals
Centric Medical™ Announces FDA Clearance of Hammertoe Correction System
August 09, 2016 HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for…
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Hospitals
Relievant Medsystems, Inc. Receives FDA 510(k) Clearance for INTRACEPT® for the Relief of Chronic Low Back Pain
REDWOOD CITY, Calif., July 21, 2016 /PRNewswire/ — Relievant Medsystems, Inc., a privately held medical device company pioneering the therapy of nerve…
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Hospitals
Alafair Biosciences Receives FDA 510(k) Clearance for VersaWrap™ Tendon Protector
July 11, 2016 AUSTIN, Texas–(BUSINESS WIRE)–Alafair Biosciences Inc., an emerging medical device company, announced today that it received 510(k)…
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Extremities
Centric Medical™ Announces 510k Approval of Subtalar Arthroereisis Implant System for Foot and Ankle
June 23, 2016 HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for…
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Hospitals
Spinal Elements® Receives 510(k) Clearance for Expandable Interbody Device
CARLSBAD, CA (PRWEB) JUNE 21, 2016 Spinal Elements, a spine technology company, announced that they have received 510(k) clearance…
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Hospitals
SI-BONE, Inc. Announces 510(k) Clearance for Updated Indication for the iFuse Implant System®
SAN JOSE, Calif., June 13, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse…
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Hospitals
Corin’s Optimized Positioning System (OPS™) receives 510(k) clearance
Corin is pleased to announce United States 510(k) clearance of the Optimized Positioning System (OPS™), the first FDA-cleared technology to…
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Hospitals
Amplitude Surgical Files for American FDA 510(k) Approval for Its Posterior-Stabilized Knee Prosthesis ANATOMIC
VALENCE, France–(BUSINESS WIRE)–Regulatory News: Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global…
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Hospitals
Avitus Orthopaedics Receives 510(k) Clearance and Launches the Avitus™ Bone Harvester
FARMINGTON, CT (PRWEB) JUNE 08, 2016 Avitus Orthopaedics Inc.(Avitus), a developer of medical devices that improve outcomes while decreasing healthcare…
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Hospitals
Additive Orthopaedics Announces the 510(k) Clearance of Their 3D Printed Digital Fusion Implant for the Global Extremities Market
LITTLE SILVER, N.J., June 1, 2016 /PRNewswire/ — Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that is has received…
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