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

FMF 2019-10-09

Nipro Syringe

Applicant Nipro Medical Corporation

K-Number K191359

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LLZ 2019-10-09

DynaCAD

Applicant Invivo Corporation

K-Number K192200

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OUP 2019-10-09

The Cellfina System

Applicant Ulthera, Inc.

K-Number K192185

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DQX 2019-10-09

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

Applicant Phenox Limited

K-Number K191687

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IYO 2019-10-09

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000

Applicant Mednovel Technology, Ltd.

K-Number K190314

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MBI 2019-10-09

Parcus Synd-EZ Ti

Applicant Parcus Medical, LLC

K-Number K191783

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DZE 2019-10-09

AnyRidge Octa 1 Implant System

Applicant Megagen Implant Co., Ltd.

K-Number K182448

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HRX 2019-10-09

Arcadia Balloon Catheter

Applicant Merit Medical Systems, Inc.

K-Number K191596

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KLE 2019-10-09

Visalys Restorative Primer

Applicant Kettenbach GmbH & Co. KG

K-Number K191523

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BTR 2019-10-09

SolidAIRity III Airway Stabilization System

Applicant Securisyn Medical, LLC

K-Number K190630

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ODB 2019-10-08

ScopeSeal Duodenoscope Protective Device

Applicant Gi Scientific, LLC

K-Number K183171

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PHX 2019-10-08

32mm Glenosphere and Humeral Cup

Applicant Fx Shoulder USA, Inc.

K-Number K192206

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