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

HQD 2017-07-17

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)

Applicant Bausch + Lomb, Incorporated

K-Number K171404

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LPH 2017-07-17

U2 Femoral Head

Applicant United Orthopedic Corporation

K-Number K162957

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LLZ 2017-07-17

3D Endo Software

Applicant Dentsply Sirona

K-Number K171115

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FRO 2017-07-17

BD ChloraShield IV Dressing with CHG Antimicrobial

Applicant Avery Dennison Belgie Bvba

K-Number K170407

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GDW 2017-07-14

Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

Applicant Golden Stapler Surgical Co., Ltd.

K-Number K162707

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MWI 2017-07-14

Dictum Health

Applicant Dictum Health, Inc.

K-Number K170798

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JLW 2017-07-14

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Applicant Shenzhen New Industries Biomedical Engineering Co., Ltd.

K-Number K162698

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HCG 2017-07-14

MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System

Applicant Codman & Shurtleff, Inc.

K-Number K171747

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DZE 2017-07-14

Bonafix TWO - Dental Implant System

Applicant Bonafix Surgical and Dental Implants

K-Number K162853

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LNH 2017-07-14

SIGNA Premier

Applicant Ge Medical Systems, LLC

K-Number K171128

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DSY 2017-07-14

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts

Applicant Vascutek, Ltd.

K-Number K162803

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DCK 2017-07-14

VITROS Chemistry Products hsCRP Reagent

Applicant Ortho Clinical Diagnostics

K-Number K160712

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