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
Nightwear Aligners
Smylio, Inc.
Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)
Intradin (Shanghai) Machinery Co., Ltd.
Elekta Unity
Elekta Solutions AB
Transorb Self-Gripping Resorbable Mesh
Sofradim Production
Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Las
Convergent Laser Technologies
Best Glove-Nitrile Powder Free Examination Glove
Bestsafe Glove Co., Ltd.
BD CTGCTV2
Bd Integrated Diagnostic Solutions/Becton,
Access OV Monitor
Beckman Coulter, Inc.
Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (
Stryker Sustainability Solutions
da Vinci SP Advanced Access Port Kit (432701)
Intuitive Surgical, Inc.
OMNI Ultra Surgical System (1-110)
Sight Sciences, Inc.
Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
WEBEST Biotech,, LLC
Trivicta Hip Stem
Ortho Development Corp.
REMI Remote EEG Monitoring System
Epitel, Inc.
Mobility Scooter (BC-MS310)
Ningbo Baichen Medical Devices Co., Ltd.
Maestro System (REF100)
Moon Surgical
ArteVu
Cardio Ring Technologies, Inc. Taiwan Branch
G-Tech Wireless Patch System (WPS)
G-Tech Medical
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxc
Ningbo Maxcon Medical Technology Co., Ltd.
NPseal
Guard Medical, Inc.
PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
Bard Access Systems, Inc.
HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)
Procept Biorobotics
FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
FMD Co., Ltd.
APEX 3D Total Ankle Replacement System
Paragon 28, Inc.
Alltest Pregnancy Rapid Combo Test Cassette
Hangzhou AllTest Biotech Co., Ltd.
VASSALLO GT Crossing14
Filmec Co. , Ltd.
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
Maine Molecular Quality Controls, Inc.
Segmentron Viewer
DGNCT, LLC
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
Sysmex America, Inc.
Sonix Health
Ontact Health Co., Ltd.
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