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

PJB 2019-09-06

Steerable catheter control system

Applicant Stereotaxis, Inc.

K-Number K183027

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HSB 2019-09-06

TTC Phantom Intramedullary Nail System

Applicant Paragon 28, Inc.

K-Number K191782

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QIA 2019-09-06

Klinly Ultrasonic Tongue Cleaner

Applicant Kea Products, Ltd.

K-Number K181986

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OCX 2019-09-06

Vacutore Air/Water Bottle Tubing

Applicant Smartdata Suzhou Co., Ltd.

K-Number K191366

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EOB 2019-09-06

Precision S 4K Sinuscope

Applicant Stryker

K-Number K191102

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MVR 2019-09-06

Gem FlowCoupler System

Applicant Baxter/ Synovis Micro Companies Alliance, Inc.

K-Number K190499

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HEW 2019-09-06

Transvaginal Access Platform

Applicant Applied Medical Resources Corp.

K-Number K191294

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JAK 2019-09-06

Aquilion ONE (TSX-306A/3) V10.0

Applicant Canon Medical Systems Corporation

K-Number K192188

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BTR 2019-09-06

Yikang Endotracheal Tube

Applicant Jiangxi Yikang Medical Instrument Group Co., Ltd.

K-Number K190213

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GKZ 2019-09-06

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer

Applicant Beckman Coulter

K-Number K182886

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EOQ 2019-09-06

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

Applicant Pentax of America, Inc.

K-Number K183516

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DPW 2019-09-06

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes

Applicant Huntleigh Healthcare , Ltd.

K-Number K183574

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