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

NKG 2017-05-18

The Solstice OCT System

Applicant Life Spine, Inc.

K-Number K170804

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ONY 2017-05-18

SmartByte Device

Applicant Scientific Intake

K-Number K171165

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MUU 2017-05-18

Lipogems System

Applicant Lipogems International Spa

K-Number K171135

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MAI 2017-05-18

HEALIX ADVANCE Anchor with PERMATAPE Suture

Applicant Medos International SARL

K-Number K170639

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NLH 2017-05-18

Supreme and Response Electrophysiology Catheters

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K161272

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MQB 2017-05-17

Nexus DR Digital X-ray Imaging System

Applicant Varex Imaging Corporation

K-Number K171138

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DXN 2017-05-17

A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor

Applicant A&D Company, Ltd.

K-Number K170196

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DZE 2017-05-17

MRI Compatibility for Existing Zimmer Dental Implant Systems

Applicant Zimmer Dental, Inc.

K-Number K160398

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LTJ 2017-05-17

FREND PSA PLUS (reagent cartridge)

Applicant Nanoentek USA, Inc.

K-Number K162378

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DRT 2017-05-17

Cardiac Trigger Monitor

Applicant Ivy Biomedical Systems, Inc.

K-Number K170828

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PHX 2017-05-17

Humeris Shoulder

Applicant Fx Solutions

K-Number K163669

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CAF 2017-05-17

AirLife Misty Finity Nebulizer

Applicant Care Fusion

K-Number K153748

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