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

DXN 2019-08-02

Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K-Number K181154

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BTG 2019-08-02

Single Use Cytology Brush BC-205D

Applicant Olympus Medical Systems Corp.

K-Number K190293

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JOJ 2019-08-02

Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape

Applicant Intertape Polymer, Inc.

K-Number K191741

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MWI 2019-08-02

DynoSense Vital Sign Measuring System

Applicant Dynosense Corp.

K-Number K190090

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CCW 2019-08-02

APA Oxy Blade

Applicant Venner Medical (Singapore) Pte, Ltd.

K-Number K191602

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PTD 2019-08-02

PowerFlow Implantable Apheresis IV Port

Applicant C.R. Bard, Inc.

K-Number K191143

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OWI 2019-08-02

JAZZ PF

Applicant Implanet, S.A.

K-Number K191217

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DQX 2019-08-01

MINAMO

Applicant Asahi Intecc Co., Ltd.

K-Number K190176

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NUC 2019-08-01

JO Premium Jelly Original Personal Lubricant

Applicant United Consortium

K-Number K191214

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PKL 2019-08-01

Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip

Applicant Olympus Medical Systems Corp.

K-Number K183590

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DYB 2019-08-01

Steerable Introducer

Applicant Freudenberg Medical, LLC

K-Number K191190

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DRB 2019-08-01

Biotronik Stylets

Applicant Biotronik, Inc.

K-Number K191469

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