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

NGT 2018-06-21

0.9% Sodium Chloride Injection, USP

Applicant Medline Industries, Inc.

K-Number K173348

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PHX 2018-06-21

Integra TITAN Reverse Shoulder System

Applicant Integra LifeSciences Corporation

K-Number K173717

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MQB 2018-06-21

Eclipse II

Applicant Carestream Health, Inc.

K-Number K180809

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CAF 2018-06-21

HOMED Mesh Nebulizer

Applicant Shenzhen Homed Medical Device Co., Ltd.

K-Number K170886

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FDF 2018-06-21

Pure Vu System

Applicant Motus GI Medical Technologies , Ltd.

K-Number K181437

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FMI 2018-06-21

Kopac Sterile Needle

Applicant Poonglim Pharmatech, Inc.

K-Number K172483

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DXN 2018-06-21

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software

Applicant Healthstats International Pte. , Ltd.

K-Number K173028

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KCT 2018-06-21

Straumann BLX Surgical Cassette

Applicant Institut Straumann AG

K-Number K180791

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FEO 2018-06-20

Swiss LithoClast Trilogy

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

K-Number K181364

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HWC 2018-06-20

Fracture and Correction System

Applicant In2bones USA, LLC

K-Number K180377

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OAP 2018-06-20

HairMax Laser

Applicant Lexington International, LLC

K-Number K180885

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NRY 2018-06-20

Penumbra System

Applicant Penumbra, Inc.

K-Number K180008

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