Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

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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OHS 2022-03-23

Project E Beauty LED Light Therapy Mask (Model: PE730)

Applicant Duplex International Trading Limited

K-Number K214101

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KWY 2022-03-23

COPAL exchange G hip spacer

Applicant Heraeus Medical GmbH

K-Number K220492

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HQF 2022-03-23

Iridex 810 Laser

Applicant Iridex Corporation

K-Number K213592

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QEW 2022-03-23

Pounce Thrombectomy System

Applicant Surmodics,Inc.

K-Number K220501

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GEI 2022-03-22

PLEXR PLUS

Applicant Gmv S.R.L.

K-Number K210693

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