Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DQA 2022-11-08

Oxyfit Pulse Oximeter

Applicant Shenzhen Viatom Technology Co., Ltd.

K-Number K203812

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OCX 2022-11-08

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing

Applicant Diversatek Healthcare

K-Number K222734

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KNF 2022-11-08

Sonata Transcervical Fibroid Ablation System 2.2

Applicant Gynesonics, Inc.

K-Number K222304

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GKZ 2022-11-08

Sysmex XW-100 Automated Hematology Analyzer

Applicant Sysmex America, Inc.

K-Number K210346

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DQY 2022-11-08

SelectSite C304 Deflectable Catheter System, C315 Delivery System

Applicant Medtronic

K-Number K223178

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QFM 2022-11-08

EFAI ChestSuite XR Pneumothorax Assessment System

Applicant Ever Fortune.Ai, Co., Ltd.

K-Number K221552

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PGY 2022-11-08

Hisense LCD monitor HMD2G21S, HMD3G21S

Applicant Qingdao Hisense Medical Equipment Co., Ltd.

K-Number K222132

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LZA 2022-11-07

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

Applicant Safesource Direct, LLC

K-Number K222898

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EGS 2022-11-07

Lotus Prophy Angle

Applicant Ajk Engineering, Inc.

K-Number K220346

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GEX 2022-11-07

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)

Applicant Sanhe Laserconn Tech Co., Ltd.

K-Number K222800

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DQK 2022-11-07

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

Applicant Edwards Lifeciences, LLC

K-Number K223127

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PHX 2022-11-07

Humeris® 135 Shoulder System

Applicant Fx Shoulder USA, Inc.

K-Number K222936

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