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

EBZ 2020-08-07

D-LUX+

Applicant DiaDent Group International

K-Number K200809

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ONB 2020-08-07

ProSeal™ Closed System drug Transfer Device (CSTD)

Applicant Epic Medical Pte. , Ltd.

K-Number K192075

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HIS 2020-08-07

CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))

Applicant Cupid Limited

K-Number K201067

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NDC 2020-08-07

EndoTool IV System

Applicant Monarch Medical Technologies, LLC

K-Number K201619

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IYE 2020-08-07

TaiChiA

Applicant Our United Corporation

K-Number K193207

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JAK 2020-08-07

VIDAvision

Applicant Vida Diagnostics, Inc.

K-Number K200990

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OLO 2020-08-07

K2M Navigation Instruments

Applicant K2m, Inc.

K-Number K201006

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KRA 2020-08-07

Fountain ValveTip Infusion Catheter

Applicant Merit Medical Systems, Inc.

K-Number K193082

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JOW 2020-08-06

ManaFlow

Applicant Manamed, Inc.

K-Number K200353

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HQF 2020-08-06

Vitra 810

Applicant Quantel Medical

K-Number K201502

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KRA 2020-08-06

ClariVein IC

Applicant Merit Medical Systems, Inc.

K-Number K201907

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FMI 2020-08-06

TK Safety Needle

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K-Number K191644

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