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

FXX 2021-08-19

CiRx (R) Surgical Mask

Applicant Ningbo Shun YE Medical Company, Ltd.

K-Number K210256

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OLO 2021-08-19

GX Navigation Instrument System

Applicant Life Spine, Inc.

K-Number K202836

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IYN 2021-08-18

Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System

Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

K-Number K210318

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FXX 2021-08-18

Surgical mask

Applicant Jiangsu Xingtong Biotechnology Group Co., Ltd.

K-Number K211454

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PIF 2021-08-18

EnteraLoc Flow

Applicant Vonco Products

K-Number K210971

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NKG 2021-08-18

QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments

Applicant Globus Medical, Inc.

K-Number K211957

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KJJ 2021-08-18

Triton

Applicant Inter-Med / Vista Dental

K-Number K211813

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PFW 2021-08-18

sam X1 Long Duration Ultrasound Device

Applicant ZetrOZ Systems, LLC

K-Number K211513

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DHA 2021-08-18

Elecsys HCG STAT

Applicant Roche Diagnostics

K-Number K203227

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CAF 2021-08-18

Hailie Sensor NF0109

Applicant Adherium (Nz), Ltd.

K-Number K211233

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FXX 2021-08-18

Disposable medical surgical mask

Applicant Hebei Titans Hongsen Medical Technology Co., Ltd.

K-Number K212097

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OWN 2021-08-18

Cellvizio I.V.E. system with Confocal Miniprobes

Applicant Mauna Kea Technologies

K-Number K212322

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