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 2020-08-19

Asept Surgical Face Mask

Applicant Pfm Medical, Inc.

K-Number K201137

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IYE 2020-08-19

Cranial 4Pi Immobilization

Applicant Brainlab AG

K-Number K202050

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DQA 2020-08-19

Reusable and Disposable SpO2 Sensors

Applicant Xinkang Medical Instrument Co. , Ltd.

K-Number K201360

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NKB 2020-08-18

ORION Spinal System

Applicant Orion Biotech, Inc.

K-Number K190600

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DZE 2020-08-18

Keystone Dental XL Dental Implant System

Applicant Keystone Dental, Inc.

K-Number K201334

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EBI 2020-08-18

BB Base 3D printing resin for denture base

Applicant Enlighten Materials Co., Ltd.

K-Number K191591

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EIH 2020-08-18

Coloring Liquid

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K192723

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KNW 2020-08-18

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System

Applicant Devicor Medical Products, Inc.

K-Number K202012

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MQR 2020-08-17

WallFlex Colonic Stent System with Anchor Lock Delivery System

Applicant Boston Scientific Corporation

K-Number K201159

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MQL 2020-08-17

Sperm Freeze, Sperm Fridge

Applicant Kitazato Corporation

K-Number K192845

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QEY 2020-08-17

EKOS PE Endovascular Device with Control System 4.0 (CS4.0)

Applicant Ekos Corporation

K-Number K200648

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MOT 2020-08-17

RadGil2

Applicant R3 X-Ray L.L.C

K-Number K201177

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