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

QEW 2022-12-20

Indigo Aspiration System - Lightning Flash

Applicant Penumbra, Inc.

K-Number K222358

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NRY 2022-12-20

Penumbra System (Reperfusion Catheter RED 43)

Applicant Penumbra, Inc.

K-Number K222808

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DZE 2022-12-20

Bonafix 2 Plus

Applicant Zentek Medical, LLC

K-Number K213677

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QAI 2022-12-20

AI.ME System

Applicant Venus Concept USA, Inc.

K-Number K221011

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PML 2022-12-20

Invictus® Bone Cement, Invictus Spinal Fixation System

Applicant Alphatec Spine, Inc.

K-Number K221926

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MHX 2022-12-20

EK12 V2 Algorithm

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K221904

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GCJ 2022-12-20

HOPKINS Telescopes

Applicant Karl Storz Endoscopy America, Inc.

K-Number K221004

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OHS 2022-12-20

LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)

Applicant Light Tree Ventures Europe B.V.

K-Number K221775

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MQV 2022-12-20

Mineral Collagen Composite Bioactive Moldable

Applicant Collagen Matrix, Inc.

K-Number K221735

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NDN 2022-12-20

SpineJack® Expansion Kit

Applicant Stryker Instruments

K-Number K223294

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NXC 2022-12-20

Al Smile Aligner

Applicant Nanjing Jiahe Dental Technology Co., Ltd.

K-Number K222308

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FLL 2022-12-20

Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K-Number K221039

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