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

GEX 2019-09-10

Pioneer Elite Diode Laser

Applicant CAO Group, Inc.

K-Number K181602

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PEM 2019-09-10

BH Medical Dental Barrier Sleeves and Barrier Film

Applicant Bh Medical Products Co., Ltd.

K-Number K190484

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DRN 2019-09-10

External Counterpulsation System

Applicant Vamed Medical Instrument Co., Ltd.

K-Number K190683

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GEX 2019-09-10

Sterling Supreme Diode Laser

Applicant CAO Group, Inc.

K-Number K181614

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OHV 2019-09-09

Sofacia System

Applicant Sofwave Medical, Ltd.

K-Number K191421

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LDS 2019-09-09

Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector

Applicant Cenorin, LLC

K-Number K183444

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GCJ 2019-09-09

Connected OR Hub with Device and Voice Control

Applicant Stryker

K-Number K192172

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GEX 2019-09-09

Precise SHP Diode Laser

Applicant CAO Group, Inc.

K-Number K181601

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ODP 2019-09-09

Ti3Z Cervical Interbody System

Applicant Zavation Medical Products, LLC

K-Number K191354

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MOS 2019-09-09

Encompass 15 Channel Head Coil, 3T

Applicant Qfix

K-Number K190668

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NUH 2019-09-07

Focus TENS Therapy, Model PM710-M/-L

Applicant Omron Healthcare, Inc.

K-Number K183215

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MEG 2019-09-06

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use

Applicant Jiangsu Micsafe Medical Technology Co., Ltd.

K-Number K183665

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