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
LiverSmart
Resonance Health Analysis Services Pty, Ltd.
ProstatID
Scanmed, LLC
SimpleStitch Suturing System
Envision Endoscopy
Rhino Non-sterile Powder-Free Nitrile Exam Glove Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
Rhino Health, Inc.
Aptima Neisseria gonorrhoeae Assay
Hologic, Inc.
Kinos Total Ankle System
Restor3D
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
Hong Qiangxing (Shenzhen) Electronics Limited
ARTFX Trauma Bone Plate and Screw System
Artfx Medical
UltraClear Laser System (N/A)
Acclaro Corporation
Change Healthcare Stratus Imaging PACS
Change Healthcare Canada Company
TRAUMAGEL® 2.0 Hemostatic Gel
Cresilon, Inc.
Navigated Instruments
Tyber Medical, LLC
Single Use CO2 Laser Fiber (HAF005001)
Quanta System Spa
Notal Vision Home Optical Coherence Tomography (OCT) System
Notal Vision, Inc.
EyeBOX (Model EBX-4)
Oculogica, Inc.
Rapid Surgical Plan (RSP-SW-001)
Navbit Pty, Ltd.
Quantisal II Oral Fluid Collection Device
Immunalysis Corporation
Infinity Pro, Logic, Quality, Sprint
Olsen Indústria E Comércio S.A.
Flowart
Asset Medikal Tasarim As.
Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF Sy
INNO Holdings Inc. DBA Innovasis
EL CAPITAN Anterior Lumbar Interbody Fusion System
Astura Medical
Dyflex-II
Taeyeon Medical Co., Ltd.
Solar Lumbar Interbody Fusion System
Degen Medical, Inc.
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
Syntheon
NAMIC Dilator and Sheath
Medline Industries, LP
Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endosc
Scivita Medical Technology Co., Ltd.
HKT Anatomical Locking Trauma System
Hankil Tech Medical Co., Ltd.
Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
Chongqing Rob Linka Science and Technology Co., Ltd.
ISAAC Neurovascular Navigation Catheter
Microvention Inc. d/b/a Terumo Neuro
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
Sysmex America, Inc.
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