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

QJP 2020-04-18

Route 92 Medical 088 Access System, 110 cm

Applicant Route 92 Medical, Inc.

K-Number K200121

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MQR 2020-04-17

WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System

Applicant Boston Scientific Corporation

K-Number K200257

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PNN 2020-04-17

BRUIS Software Suite

Applicant Mechanodontics, Inc.

K-Number K191720

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OAP 2020-04-17

Irradiation Cosmetic Device

Applicant Chongqing Peninsula Medical Technology Co., Ltd.

K-Number K192552

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ITX 2020-04-17

Opticross 35 15 MHz Peripheral Imaging Catheter

Applicant Boston Scientific Corporation

K-Number K200733

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OVD 2020-04-17

ProLift Lateral Fixated

Applicant Life Spine, Inc.

K-Number K200338

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KWY 2020-04-17

Kyocera Bipolar Hip System

Applicant Kyocera Medical Technologies, Inc.

K-Number K200709

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IYN 2020-04-17

LOGIQ E10

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K200158

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HGX 2020-04-17

Rumble Tuff Electric Breast Pump

Applicant A Cute Baby, Inc.

K-Number K200712

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GEX 2020-04-17

Diode Laser Therapy Device

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K200118

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OUR 2020-04-17

SI-Restore Sacroiliac Joint Fixation System

Applicant Biofusion Medical

K-Number K200868

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GKZ 2020-04-16

Unicel DxH 800 Coulter Cellular Analysis System

Applicant Beckman Coulter

K-Number K193124

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