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

EKX 2018-08-20

Young INFINITY Cordless Handpiece System

Applicant Young Dental Manufacturing Co. 1, LLC

K-Number K171377

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FMI 2018-08-20

BD Vacutainer Eclipse Signal Blood Collection Needle

Applicant Becton, Dickinson and Company

K-Number K170824

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HEB 2018-08-20

re.t.a Reuseable Tampon Applicator

Applicant Thinx, Inc.

K-Number K180850

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KNW 2018-08-20

BEXCORE Breast Biopsy System, Biopsy Needle

Applicant Medical Park Co., Ltd.

K-Number K171890

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NFT 2018-08-20

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

Applicant Safecare Biotech (Hangzhou) Co., Ltd.

K-Number K181968

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NFT 2018-08-20

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests

Applicant Assure Tech. (Hangzhou) Co, Ltd.

K-Number K181768

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OWB 2018-08-17

OSCAR (OSCAR Prime, OSCAR Classic)

Applicant Genoray Co., Ltd.

K-Number K181943

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FMT 2018-08-17

NuBorne Infant Warmer

Applicant International Biomedical

K-Number K173516

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MQV 2018-08-17

Actifuse Flow

Applicant Baxter Healthcare Corporation

K-Number K181306

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ONB 2018-08-17

Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor

Applicant J & J Solutions, Inc. D/B/A/ Corvida Medical

K-Number K180574

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DQD 2018-08-17

Electronic Stethoscope DS3011A

Applicant Imediplus, Inc.

K-Number K173663

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EIA 2018-08-17

Forest Dental Unit

Applicant Forest Dental Products, Inc.

K-Number K173608

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