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

DXN 2018-10-06

Bluetooth blood pressure monitor

Applicant Shenzhen Kingyield Technology Co., Ltd.

K-Number K182018

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HRS 2018-10-05

ORTHOLOC SPS Shoulder Plating System

Applicant Tornier, Inc.

K-Number K181587

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DQY 2018-10-05

GORE Tri-Lumen Catheter

Applicant W. L. Gore and Associates, Inc.

K-Number K180919

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NHA 2018-10-05

Straumann SC Variobase Abutments

Applicant Institut Straumann AG

K-Number K173945

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LNH 2018-10-05

MAGNETOM Sola

Applicant Siemens Medical Solutions USA, Inc.

K-Number K181322

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PQK 2018-10-05

Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)

Applicant Avenu Medical, Inc.

K-Number K181725

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MAX 2018-10-05

SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices

Applicant Spineex, Inc.

K-Number K181531

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GXY 2018-10-05

Sense System with IBT Electrodes

Applicant Infinite Biomedical Technologies, LLC

K-Number K182112

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ONF 2018-10-05

SHINY RPL System

Applicant Ids, Ltd.

K-Number K181868

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NKG 2018-10-05

EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System

Applicant K2m, Inc.

K-Number K181603

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MCW 2018-10-05

B-Laser Atherectomy System

Applicant Eximo Medical, Ltd.

K-Number K181642

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DQO 2018-10-05

Royal Flush Plus High-Flow Catheter

Applicant Cook Incorporated

K-Number K180054

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