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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

ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02)

Jinhua Qidian Vehicle Co., Ltd.

Well-life TM Pen Needles, Well-life TM Safety Pen Needles

W. L. Med Co., Ltd.

ZBPro Diagnostic

Zbeats, Inc.

Straumann Variobase Abutments XC for Bridge/Bar

Institut Straumann AG

OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coro

Boston Scientific

ProMIS Extension Rod System

Premia Spine, Ltd.

MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw

Depuy Mitek

SPRY TMS Therapy System (0550)

Soterix Medical, Inc.

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters

Sophysa

Balanced Knee System TriMax Porous Femoral Components

Ortho Development Corp.

Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro,

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Disposable Biopsy Needle

Carbon (Shenzhen) Medical Device Co., Ltd.

Disposable Nitrile Examination Glove

Inner Mongolia Cureguard Medical Technology Co., Ltd.

S-Core Implant System

Subchondral Solutions, Inc.

Dione PEEK Screw System

ZheJiang Decans Medical Devices Co., Ltd.

Natural Cycles

Natural Cycles Nordic AB

SleepCheckRx

Resapp Health

SureAx-Guide™

Sureax Medical, LLC

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument

Quidel Corporation

ExactechGPS® Total Ankle Application

Blue Ortho

Pristine Arthroscopic Visualization System

Pristine Surgical

Calibra Abutment Resin Cement

Dentsply Sirona

Heat StimPlus

Famidoc Technology Co., Ltd.

CHLOE BLAST

Fairtility , Ltd.

Tactoset

Anika Therapeutics, Inc.

Geo Abutment

Geomedi Co,., Ltd.

Electric wheelchair (JJW-7002, JJW-7003)

ZheJiang J&J Mobility Co., Ltd.

Vitrea CT VScore

Canon Medical Informatics, Inc.

Clarius OB AI

Clarius Mobile Health Corp.

Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle

Sol-Millennium Medical, Inc.

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