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

EWY 2022-06-23

HD Mediastinoscope

Applicant Karl Storz Endoscopy America, Inc.

K-Number K213194

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FOZ 2022-06-23

Introcan Safety 2 IV Catheter

Applicant B.Braun Medical, Inc.

K-Number K220756

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GEI 2022-06-23

maxmorespine Bipolar Electrodes

Applicant Hoogland Spine Products, GmbH

K-Number K211173

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LLZ 2022-06-23

Axial3D Cloud Segmentation Service

Applicant Axial Medical Printing Limited

K-Number K221511

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QEW 2022-06-23

Excipio SV Thrombectomy Device

Applicant Contego Medical, Inc.

K-Number K221204

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MSQ 2022-06-23

BreathID Hp Lab System, BreathID Smart System

Applicant Meridian Bioscience Israel , Ltd.

K-Number K220494

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LZA 2022-06-22

Nitrile Examination Gloves

Applicant Hangzhou Runheng Medical Co., Ltd.

K-Number K213739

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QPP 2022-06-22

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System

Applicant Canary Medical USA, LLC

K-Number K220413

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LZA 2022-06-22

Disposable Nitrile Powder-Free Examination Gloves

Applicant Shandong Maida Medical Technology Co., Ltd.

K-Number K221192

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DQA 2022-06-22

Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)

Applicant Huizhou Xiaoou Technology Co., Ltd.

K-Number K212665

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PPW 2022-06-22

T3 Platform Software

Applicant Etiometry, Inc.

K-Number K213230

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GBM 2022-06-22

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

Applicant Convatec Limited

K-Number K213283

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