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

FPA 2016-08-25

LifeFlow Rapid Infusion Device (LifeFlow Device)

Applicant 410 Medical Innovation, LLC

K-Number K153731

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BTT 2016-08-25

AirLife Autofill Humidification Chamber

Applicant Carefusion 2200, Inc.

K-Number K160764

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NKB 2016-08-25

G Surgical Marksman MIS System

Applicant G Surgical, LLC

K-Number K161516

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HIS 2016-08-25

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)

Applicant M3 Global Enterprises, LLC

K-Number K161195

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DXN 2016-08-25

V10

Applicant Mediana Co., Ltd.

K-Number K152659

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PJA 2016-08-24

FFRct

Applicant HeartFlow, Inc.

K-Number K161772

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JAK 2016-08-24

SOMATOM Drive

Applicant Siemens Medical Solutions USA, Inc.

K-Number K161196

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NDN 2016-08-24

Kyphon HV-R Bone Cement

Applicant Medtronic, Inc.

K-Number K160983

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MAX 2016-08-24

XYcor® Expandable Spinal Spacer System

Applicant Alphatec Spine, Inc.

K-Number K160646

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FLL 2016-08-24

Infrared Forehead Thermometer, FT-100A

Applicant Hangzhou Universal Electronic Co., Ltd.

K-Number K160802

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LLZ 2016-08-24

ResolutionMD

Applicant Calgary Scientific, Inc.

K-Number K161130

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PND 2016-08-24

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology

Applicant Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K-Number K161313

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