510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
CT Lung Ventilation Analysis Software (CT:V)
4Dmedical Limited
Bonafix TiBase
Zentek Medical, LLC
Fresenius Liberty Select Cycler
Fresenius Medical Care Renal Therapies Group, LLC
Surgical Face Mask
Jiangxi Ganlong Pharmaceutical Co., Ltd.
Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
Sejoy Biomedical Co., Ltd.
Bard® Mesh; Bard® Mesh Pre-Shaped
Davol, Inc.
CT VScore+
Canon Medical Informatics, Inc.
icotec Anterior Cervical Plate System
Icotec AG
Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Le
Comfort Rubber Gloves Industries Sdn. Bhd.
Visby Medical Sexual Health Test
Visby Medical
Atlantis® Abutments in Titanium
Dentsply Sirona
Infusion Sets for Single Use
Jiangsu Suyun Medical Materials Co., Ltd.
Mais Central Venous Catheter
Saudi Mais Co. For Medical Products
Moda-flx Hemodialysis System and Cartridge
Diality, Inc.
Anti Snore Mouthpiece
Dongguan Yiyao Science & Technology Development Co., Ltd.
Salto Talaris Ankle PSI System
3D Systems, Inc.
CSF-3
Cardiacsense
DePuy CONDUIT LLIF Angled Inserters
Enztec Limited
Infinity OCT System and PASS OCT Spinal System
Medicrea International
Ossiclear (Ossiclear System)
Sounduct
LED Light Therapy Mask (model: MK66R-B)
Light Tree Ventures Europe B.V.
primaLOK SP Interspinous Fusion System
Wenzel Spine, Inc.
ClearClub Impression Material
ClearClub
AlphaVac MMA F1885 System (H787253020)
AngioDynamics, Inc.
Freedom Posterior Cervical Screws
Signature Orthopaedics Pty, Ltd.
Tidepool Loop
Tidepool Project
CVAC Aspiration System
Calyxo, Inc.
Dream Sock
Owlet Babycare, Inc.
Tera Harz Clear
Graphy, Inc.
Access AMH
Beckman Coulter, Inc.
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