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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