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

ESW 2021-07-23

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

Applicant M.I.Tech Co., Ltd.

K-Number K201160

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HSB 2021-07-23

Flex-Thread™ Distal Fibula lntramedullary Nail System

Applicant Flower Orthopedics Corporation Dba Conventus Flower

K-Number K212030

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OHT 2021-07-23

Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.

Applicant Shenzhen Mismon Technology Co., Ltd.

K-Number K210311

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NAY 2021-07-23

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K211316

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QNP 2021-07-23

GI Genius

Applicant Cosmo Artificial Intelligence - Ai, Ltd.

K-Number K211951

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NEY 2021-07-23

Disposable Microwave Therapeutic Antennas

Applicant Nanjing Eco Microwave System Co., Ltd.

K-Number K201265

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IYO 2021-07-23

SC1 Handheld Ultrasound Imaging System (Model: SC1)

Applicant Fcu Co., Ltd.

K-Number K210468

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FOZ 2021-07-23

Disposable IV catheter

Applicant Shinva Ande Healthcare Apparatus Co., Ltd.

K-Number K202060

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LLZ 2021-07-23

MySpine WebPlanner & MyBalance

Applicant Medacta International S.A.

K-Number K211386

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LZA 2021-07-22

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs

Applicant Guangdong Kingfa Sci. & Tech.Co., Ltd.

K-Number K211220

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FXX 2021-07-22

Single-use medical face mask

Applicant Zhuhai Herald Datanetics Limited.

K-Number K210391

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HWC 2021-07-22

Medline UNITE® Digital Fusion Screw System

Applicant Medline Industries, Inc.

K-Number K211944

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