U.S. FDA 510(k) Clearance
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Spine
VUZE Medical Announces U.S. FDA 510(K) Clearance for Second-Generation Software-Based 3D Guidance System for Spine Surgery
VUZE 2.0 provides much-extended interoperability and functionality; like VUZE 1.0, requires only a 2D C-arm and PC in the OR…
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Biologics
Kuros Biosciences Receives US FDA 510K Clearance for MagnetOs Granules for Interbody Use and Regulatory Clearance of MagnetOs Granules and MagnetOs Putty in New Zealand
MagnetOs™ Granules becomes the third product in the MagnetOs portfolio to receive FDA clearance to market for interbody use Kuros continues…
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Regulatory
Misonix Receives U.S. FDA Clearance For NEXUS, Its Revolutionary Integrated Ultrasonic Surgical Platform
FARMINGDALE, N.Y., (June 3, 2019) – Misonix, Inc. (Nasdaq: MSON) (“Misonix” or the “Company”), a provider of minimally invasive therapeutic…
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Regulatory
ControlRad™ Announces FDA Clearance and Launch of the Only Radiation Reduction Technology that Integrates into Mobile C-arms
May 22, 2019 ATLANTA–(BUSINESS WIRE)–ControlRad, Inc., a privately held medical technology company focused on dramatically reducing unnecessary radiation exposure during…
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Extremities
Tenex Health Announces 510(k) US FDA Clearance for TX®-Bone to Help Patients Restore Musculoskeletal Function Without Invasive Surgery
LAKE FOREST, CALIF. (PRWEB) MAY 13, 2019 Tenex Health, Inc., a privately held U.S.-based medical technology company providing healthcare professionals with…
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Hospitals
EOS imaging Announces US FDA Clearance For hipEOS 3.0 Software
June 05, 2018 EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of 2D/3D imaging and…
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