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
Lipocosm Harmonic System
Lipocosm, LLC
EzVu Visual Vasopressor injector (EV-19)
Veol Medical Technologies Pvt , Ltd.
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization Sy
Steris
BPBIO750
Inbody Co., Ltd.
Vinyl Patient Examination Gloves
Jiangxi Shengda Medical Technology Co., Ltd.
Curiteva Porous PEEK Laminoplasty System
Curiteva, Inc.
Symbia VA10A Family
Siemens Medical Solutions USA, Inc.
LGO-Surgical Laser Fibers
Light Guide Optics International , Ltd.
Anovo Surgical System (6Ne)
Momentis Surgical , Ltd.
Community Containers (Flap and Daisy)
Keter Canada, Inc.
Zeta Navigation System
Zeta Surgical, Inc.
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
Philips Medical Systems Nederland B.V.
Medline Orbis Chemo Surgical Gown
Medline Industries, LP
SteriBest® Sterilization Tray System
Mastel Surgical
AXIOS Stent and Electrocautery-Enhanced Delivery System
Boston Scientific Corporation
Bonvadis Topical Cream
Stemcyte, Inc.
Talee, Talee PostOp
Invent Medical USA, LLC
Synapse Lung Nodule AI
Fujifilm Corporation
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01,
Remington Medical, Inc.
Agile Esophageal Stent System
Boston Scientific Corporation
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
Spectrum Medical S.R.L.
Perfit CL
Vatech Mcis Co., Ltd.
Rayvolve
Azmed Sas
Transpara Density 1.0.0
Screenpoint Medical B.V.
Mobility Scooter (X-12, X-14, X-17)
Wuyi Aichi Industry and Trade Co., Ltd.
Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
Hathor Professional Skincare , Ltd.
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
STERIS Corporation
PELNAC Meshed Bilayer Wound Matrix
Gunze Limited
Yumizen H2500
HORIBA ABX SAS
SternalPlate Expansion
Stryker Leibinger GmbH & Co KG
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