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

MAX 2022-03-24

FlareHawk Interbody Fusion System

Applicant Integrity Implants, Inc.

K-Number K220453

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INI 2022-03-24

Mobility Scooter, Model W3468

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K220207

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GEX 2022-03-24

AviClear Laser System

Applicant Cutera, Inc.

K-Number K213461

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LZA 2022-03-24

Disposable Medical Synthetic Nitrile Examination Gloves

Applicant Niujian Technology Co., Ltd.

K-Number K220354

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DRC 2022-03-23

PathBuilder Transseptal Needle

Applicant Shanghai Microport EP Medtech Co., Ltd.

K-Number K212625

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IZL 2022-03-23

DRX-Rise Mobile X-ray System

Applicant Carestream Health

K-Number K213568

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DYB 2022-03-23

PathBuilder Transseptal Guiding Introducer

Applicant Shanghai Microport EP Medtech Co., Ltd.

K-Number K212626

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GCJ 2022-03-23

ArthroFree Wireless Surgical Camera System

Applicant Lazurite Holdings, LLC

K-Number K213860

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DGC 2022-03-23

Total Immunoglobulin E (IgE)

Applicant Beckman Coulter, Inc.

K-Number K220178

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FXX 2022-03-23

Disposable Medical Surgical Mask

Applicant Hubei Huaqiang High-Tech Co., Ltd.

K-Number K212726

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FQH 2022-03-23

BD Surgiphor Antimicrobial Irrigation System

Applicant Becton, Dickinson and Company

K-Number K213616

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FRO 2022-03-23

LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K210718

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