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

MCW 2022-09-06

ROTAPRO Rotational Atherectomy System

Applicant Boston Scientific Corporation

K-Number K220962

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DZE 2022-09-06

Neodent Implant System - GM Narrow Implant System

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K220251

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LNH 2022-09-06

LiverMultiScan v5 (LMSv5)

Applicant Perspectum

K-Number K213960

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FRN 2022-09-06

Spectrum IQ Infusion System with Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K-Number K222048

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DQX 2022-09-06

ASAHI Gladius Mongo18 PV ES

Applicant Asahi Intecc Co., Ltd.

K-Number K213868

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LPH 2022-09-06

EMPHASYS Acetabular System

Applicant Depuy Ireland UC

K-Number K221636

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PLP 2022-09-06

TULSA-PRO System

Applicant Profound Medical, Inc.

K-Number K211858

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ODA 2022-09-06

Smith+Nephew INTELLIO Tablet

Applicant Smith+Nephew

K-Number K221929

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LLZ 2022-09-06

Ez3D-i/E3

Applicant Ewoosoft Co., Ltd.

K-Number K222069

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GAW 2022-09-02

DURAMESH Mesh Suture

Applicant Msi

K-Number K211178

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LPL 2022-09-02

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Applicant Yung Sheng Optical Co., Ltd.

K-Number K213983

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GEI 2022-09-02

CellFX System

Applicant Pulse Biosciences, Inc.

K-Number K222075

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