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
K3900 Ultrasound Imaging System
Maui Imaging
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
Exceleron Medical
Tibial baseplate, Tibial insert
United Orthopedic Corporation
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Y
Technomed Europe
WHILL Model R
Whill, Inc.
GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (
Cosmo Artificial Intelligence - Ai, Ltd.
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
Surgical Instrument Service and Savings, Inc.
Respiratory Gating for Scanners v2.0
Varian Medical Systems, Inc.
Strauss Surgical Resection Instruments
American Medical Endoscopy, Inc.
Indigo® Aspiration System Lightning Bolt Aspiration Tubing
Penumbra, Inc.
Revolution External Plating System
New Standard Device Dba Metalogix
SofWave System
Sofwave Medical, Ltd.
Pulsenmore ES
Pulsenmore, Ltd.
Magnetic Localization Patch Kit (AFR-00021)
Medtronic, Inc.
Triton 1 System
Neptune Medical, Inc.
Genomadix Cube CYP2C19 System
Genomadix, Inc.
Ceribell Infant Seizure Detection Software
Ceribell, Inc.
Elecsys CMV IgG
Roche Diagnostics
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
Nexstim Oyj
Response Ortho Smart Fixator - Hexapod System
Response Ortho Solutions, LLC
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
Eieling Technology Limited
SKOUT Software
Iterative Scopes, Inc.
Polyver Silver Alginate Dressing (Prescription and OTC)
Roosin Medical Co., Ltd.
F65 Laser System
Lumenis Be, Ltd.
Cautery Protective Actuation System (CPAS)
Safer Surgeries Medical Devices, LLC
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
Carolina Liquid Chemistries Corp.
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection)
Teleflex Medical
ACUTRON
Ilooda Co,., Ltd.
Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ De
Indiba S. A. U.
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
Qura S.R.L
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