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

NGT 2019-07-12

AMSafe(R) Pre-Filled Normal Saline Flush Syringe

Applicant Amsino International, Inc.

K-Number K183473

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EBF 2019-07-12

Novidia Bulk Fill Flow Composite

Applicant Nobio , Ltd.

K-Number K182714

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NBY 2019-07-12

StitchKit

Applicant Origami Surgical

K-Number K191317

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NAY 2019-07-12

SureForm 45 Curved Tip, SureForm 45 Gray Reload

Applicant Intuitive Surgical, Inc.

K-Number K190999

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LNH 2019-07-12

MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow

Applicant Siemens Medical Solutions USA, Inc.

K-Number K191050

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NHA 2019-07-12

Osstem Abutment System

Applicant Osstem Implant Co., Ltd.

K-Number K182091

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HRX 2019-07-12

Stryker CrossFlow Integrated Arthroscopy Pump

Applicant Stryker Corp.

K-Number K191259

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HRX 2019-07-11

Nuvis Battery Arthroscope

Applicant Integrated Endoscopy, Inc.

K-Number K191594

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EMA 2019-07-11

GC FujiCEM 2 (Improved)

Applicant GC America, Inc.

K-Number K182854

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NAY 2019-07-11

Senhance Surgical System

Applicant Transenterix, Inc.

K-Number K191482

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HRX 2019-07-11

Voyant System

Applicant Viseon, Inc.

K-Number K191579

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GZB 2019-07-11

Nalu Lead Blank (50cm)

Applicant Boston Scientific Neuromodulation

K-Number K190960

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