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

NUH 2021-06-04

Perfect EMS

Applicant Tenscare, Ltd.

K-Number K200694

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IPF 2021-06-03

Intellihab System

Applicant Cymedica Orthopedics, Inc.

K-Number K210604

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NKB 2021-06-03

ASTRA Spine System

Applicant Spinecraft, LLC

K-Number K211323

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DYB 2021-06-03

Breezeway II

Applicant Oscor, Inc.

K-Number K210627

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DSA 2021-06-03

PCA-C1 series Patient Cable

Applicant QT Medical, Inc.

K-Number K200722

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FXX 2021-06-03

Allmed Surgical Face Masks (Ear loops)

Applicant Allmed Medical Products Co., Ltd.

K-Number K202128

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GEX 2021-06-03

SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

Applicant Gyrus Acmi, Inc.

K-Number K211401

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FXX 2021-06-02

Disposable Medical mask

Applicant Hubei Wanli Protective Products Co., Ltd.

K-Number K210150

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FXX 2021-06-02

ASM-301 Level 3 Surgical Mask

Applicant American Surgical Mask Company, LLC

K-Number K211440

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NXC 2021-06-02

6MS Invisible Aligner

Applicant Sms Opco, LLC

K-Number K210652

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FXX 2021-06-02

Disposable Surgical Face Mask

Applicant Jiangxi Heying Pharmaceutical Co., Ltd.

K-Number K210429

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QDQ 2021-06-02

Transpara 1.7.0

Applicant Screenpoint Medical B.V.

K-Number K210404

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