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

DXN 2020-05-15

BP-BT Kiosk

Applicant Ld Technology, LLC

K-Number K200287

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ONF 2020-05-15

IPL Treatment Systems

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K200746

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OQU 2020-05-15

SonarMed AirWave Airway Monitoring System

Applicant Sonarmed, Inc.

K-Number K193058

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OCX 2020-05-15

AquaPulse Auxiliary Water Connector

Applicant Ga Health Company Limited

K-Number K200479

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HRS 2020-05-14

Skeletal Dynamics Midshaft Humerus Plating System

Applicant Skeletal Dynamics, Inc.

K-Number K200701

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DQY 2020-05-14

Support Catheter

Applicant Qxmedical, LLC

K-Number K200317

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JAK 2020-05-14

XV Lung Ventilation Analysis Software

Applicant 4Dx Limited

K-Number K193293

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QPB 2020-05-14

PAL Single-Use Cannulas

Applicant Microaire Surgical Instruments

K-Number K192694

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FRO 2020-05-14

Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border

Applicant Winner Medical Co., Ltd.

K-Number K191819

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LPH 2020-05-14

KeYi Total Hip System

Applicant Beijing Keyi Medical Device Technology Co., Ltd.

K-Number K191826

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NIG 2020-05-14

Lumipulse G CA19-9-N

Applicant Fujirebio Diagnostics,Inc.

K-Number K200997

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NZA 2020-05-14

Reliance Endoscope Processing System

Applicant STERIS Corporation

K-Number K200989

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