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

FEO 2018-10-09

Swiss LithoClast Trilogy

Applicant E.M.S Electro Medical Systems S.A

K-Number K182490

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NAY 2018-10-09

Senhance Surgical System

Applicant Transenterix, Inc.

K-Number K181517

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LLZ 2018-10-09

Ziostation2

Applicant Ziosoft, Inc.

K-Number K181892

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OVD 2018-10-09

Scarlet AL-T

Applicant Spineart

K-Number K181818

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LYZ 2018-10-06

Vinyl Patient Examination Gloves

Applicant Jiangxi Zhonghong Pulin Medical Products Co., Ltd.

K-Number K182117

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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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QDD 2018-10-05

Bose Hearing Aid

Applicant Bose Corporation

K-Number DEN180026

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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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