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

OHV 2021-11-15

SofWave System

Applicant Sofwave Medical, Ltd.

K-Number K211483

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GEX 2021-11-15

Darwin

Applicant Luvo Medical Technologies, Inc.

K-Number K212607

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NHA 2021-11-15

DS Implants abutments provided with the EV connection

Applicant Dentsply Sirona

K-Number K213449

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IRP 2021-11-15

Air Compression Massager (Model LF-FT003)

Applicant Wenzhou Lingfeng Electronic Technology Co., Ltd.

K-Number K213000

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JOW 2021-11-15

Circul8 Pro

Applicant Ortho8, Inc.

K-Number K212731

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FXX 2021-11-14

Spin Care Disposable Protective Mask Level 3

Applicant Spintech, LLC

K-Number K212109

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FXX 2021-11-14

Surgical Face Mask

Applicant Hubei Huanfu Plastic Products Co., Ltd.

K-Number K212575

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FXX 2021-11-13

Surgical Face mask

Applicant Nantong Taiweishi Medical Technology Co., Ltd.

K-Number K212264

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QOH 2021-11-13

Hemolung Respiratory Assist System

Applicant Alung Technologies, Inc.

K-Number DEN210006

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FYC 2021-11-13

Disposable Surgical Gowns

Applicant Chongqing Litai Fashion Group Limited Company

K-Number K210785

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PHX 2021-11-12

Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation

Applicant Tornier, Inc.

K-Number K211359

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NHN 2021-11-12

Erchonia FX-405

Applicant Erchonia Corporation

K-Number K212595

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