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

HQM 2019-01-30

Boston Keratoprosthesis, Type I Lucia

Applicant Massachusetts Eye and Ear Infirmary D/B/A Boston

K-Number K182986

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PHX 2019-01-30

Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid

Applicant Tornier, Inc.

K-Number K183696

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LZO 2019-01-30

Zimmer Segmental System Proximal Femoral Component

Applicant Zimmer, Inc.

K-Number K183136

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DSA 2019-01-30

Patient Cables and Leadwires , Disposable ECG Leadwires

Applicant Orantech, Inc.

K-Number K182327

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MOF 2019-01-29

ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010

Applicant Asahi Intecc Co., Ltd.

K-Number K183070

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NHA 2019-01-29

Cortex CAD/CAM Abutments

Applicant Cortex Dental Implants Industries , Ltd.

K-Number K181580

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PBX 2019-01-29

T-PLUS

Applicant Wintecare SA

K-Number K181893

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POL 2019-01-29

Solitaire 4 Revascularization Device

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K183022

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HAW 2019-01-29

AQrate Robotic Assistance System

Applicant Globus Medical, Inc.

K-Number K182000

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CDZ 2019-01-29

FastPack IP Sex Hormone Binding Globulin Immunoassay

Applicant Qualigen, Inc.

K-Number K182521

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IYN 2019-01-29

X5 Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K182648

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MAX 2019-01-29

Neo Cage System TM

Applicant Neo Medical SA

K-Number K181048

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