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

FLL 2021-07-23

Infrared Forehead Thermometer, Model BSX976

Applicant Shenzhen Bsx Technology Electronics Co., Ltd.

K-Number K202296

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DYB 2021-07-23

CardioCurve Steerable Sheath

Applicant Talon Surgical

K-Number K210185

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KPO 2021-07-23

HMB32 Dialysis Solution

Applicant Haemopharm Biofluids S.R.L.

K-Number K212052

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NHA 2021-07-23

IS Multi Unit Abutment System

Applicant Neobiotech Co., Ltd.

K-Number K210903

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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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