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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

Mico One Orthodontic Screw

Ze Fang Technology Co., Ltd.

JetBoots PRO Plus

Therabody, Inc.

Power Mobility Scooter (MJMA01, MJMA02)

Nanjing Mijo Technology Co., Ltd.

Clarius Bladder AI

Clarius Mobile Health Corp.

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

Shenzhen Vitavitro Biotech Co., Ltd.

Vivo 3

Breas Medical AB

safety lancet

Tianjin Huahong Technology Co., Ltd.

PATHFAST®hs-cTnI-II

Phc Corporation

Equinoxe® Shoulder System

Exactech, Inc.

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

Lithoblast Single Use Holmium Laser Fibers

Dawell Medical, LLC

InVision Precision LVEF (LVEF)

InVision Medical Technology Corporation

Minuteman G5 MIS Fusion Plate

Spinal Simplicity, LLC

Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Us

Hartalega NGC Sdn. Bhd.

Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)

Tianjin Huahong Technology Co., Ltd.

MyEllevate

Cynosure, LLC

Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR1

Hunan Endoso Life Technology Co., Ltd.

IPL Hair Removal Device (BE932C, BE932D, BE932E)

Shenzhen Yang WO Electronic Co., Ltd.

QUANTUM® Patient Specific Instrumentation (PSI) System

In2bones Sas

MEMO Patch M (MPT-E08R-UNC01)

Huinno Co., Ltd.

High Retention Attachment System

Zest Anchors, LLC

SKR 3000

Konica Minolta, Inc.

Anatase Navi Disposable Instrument

Remex Medical Corp.

Smooth Drive contra angle and straight handpieces

Lares Research

Pulsenmore ES

Pulsenmore, Ltd.

IdentiTi ALIF Interbody Systems

Alphatec Spine, Inc.

Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)

Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd

Fixone Meniscal Repair

Aju Pharm Co., Ltd.

Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

Acuity Polymers, Inc.

Rosa® Knee System

Orthosoft Inc. (d/b/a) Zimmer CAS

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