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
Vena MicroAngioscope System
Vena Medical Holdings Corp
Arthrex Bioabsorbable PushLock Suture Anchors
Arthrex, Inc.
ROSA ONE Brain application
Medtech S.A.S
IPL Treatment Device (MDSQMC-01)
Medusa (Guangxi)Medical Devices Co., Ltd.
TearCare MGX System
Sight Sciences, Inc.
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
Hangzhou SHINING3D Dental Technology Co., Ltd.
Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use No
Hg Innovations, Ltd.
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta , Ltd.
Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist
Convatec
tmCMF Solution
Techmah Cmf
prolaio eVO2peak Module (Version 1.0)
Prolaio, Inc.
Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minute
Spinal Simplicity, LLC
Echo-2
Neko Health AB
BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL)
Becton, Dickinson and Company
Mobius3D (4.1)
Varian Medical Systems
Disposable Medical Nitrile Examination Gloves
Hebei Titans Hongsen Medical Technology Co., Ltd.
Rx Knee System
Signature Orthopaedics Pty, Ltd.
BEE PLIF Cage
NGMedical GmbH
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, Lith
Boston Scientific Corporation
Precision AI Surgical Planning System (PAI-SPS)
Precision AI Pty, Ltd.
Curiteva Navigation System
Curiteva, Inc.
WHILL (WHILL Model C2)
Whill, Inc.
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
Medline Industries, Inc.
EpiFinder
Omeq Medical , Ltd.
autoSCORE (V 2.0.0)
Holberg Eeg AS
Electric Wheelchair (DF506)
Jiangsu Yveelt Medical Equipment Co., Ltd.
Guiding Catheter
CenterPoint Systems, LLC
SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
Quanta Dialysis Technologies, Ltd.
ReWalk P6.0
Re Walk Robotics , Ltd.
qXR-PTX-PE
Qure.Ai Technologies
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