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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 (0.0156–4 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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