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FDA grants 510(k) clearance to Ventris Medical’s Backpack for orthopaedic use
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ventris Medical’s Backpack (Porous Biologic ...
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Monogram Technologies Provides 510(k) Submission Update Following Positive Meeting with FDA
meeting with the U.S. Food and Drug Administration ("FDA") on December 17, 2024, regarding its 510(k) premarket filing submission for the Company's mBôs TKA System (the "Application").
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Tackling the complexities of 510(k) Submission Overcoming Rejection Barriers
Medical device manufacturers seeking global market access often prioritize the U.S. Food and Drug Administration (FDA) ...
InkSpace Imaging Receives FDA 510(k) Clearance for 1.5T 24-channel MR Coil for Siemens Healthineers
Designed for efficiency and precision, the 1.5T MR coil leverages InkSpace Imaging’s proprietary coil technology to deliver superior image quality. This enhances diagnostic confidence while ...
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AVITA Medical Announces FDA 510(k) Clearance for Cohealyx, Expanding its Addressable Market
today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Cohealyx ™, a new collagen-based dermal matrix branded by AVITA Medical and co-developed with ...
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Inogen receives FDA 510(k) clearance for SIMEOX 200 airway clearance device
Inogen, Inc., a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) ...
Inogen gets FDA 510(k) clearance for the SIMEOX 200 Airway Clearance Device
Inogen (INGN) announced that it has received U.S. Food and Drug Administration FDA 510(k) clearance for the SIMEOX 200 Airway Clearance ...