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

NOP 2016-08-10

EUROIMMUN Anti-West Nile Virus ELISA (IgG)

Applicant Euroimmun Us, Inc.

K-Number K153303

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HQD 2016-08-10

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses

Applicant Contamac, Ltd.

K-Number K161100

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OWB 2016-08-10

CT TrueView

Applicant Philips Medical Systems Nederland B.V.

K-Number K160147

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IZH 2016-08-10

Affirm Lateral Arm Upright Biopsy Accessory

Applicant Hologic

K-Number K161575

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KPL 2016-08-10

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10

Applicant Colonplus Equipments & Speculums, S.L.

K-Number K152834

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JAQ 2016-08-10

Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths

Applicant Varian Medical Systems, Inc.

K-Number K160516

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DXN 2016-08-10

Fully Automatic Electronic Blood Pressure Monitor

Applicant Andon Health Co, Ltd.

K-Number K160565

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PLC 2016-08-10

TAP 3, TAP 1

Applicant Airway Management, Inc.

K-Number K160239

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DQK 2016-08-10

Rhythm View Workstation (non-streaming)

Applicant Abbott Electrophysiology

K-Number K161240

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FPA 2016-08-10

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®

Applicant Unomedical A/S

K-Number K160648

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LPL 2016-08-10

Hidrocor, Hidrocharme, and Natural Colors

Applicant Solotica

K-Number K160472

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JJX 2016-08-10

Audit MicroControls Linearity DROP LQ Blood Glucose

Applicant Aalto Scientific, Ltd.

K-Number K161874

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