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

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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GEI 2019-10-08

Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps

Applicant Faulhaber Pinzetten Ohg

K-Number K182773

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DZE 2019-10-08

Advanced Intermezzo Implant System

Applicant Megagen Implant Co., Ltd.

K-Number K191127

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PEM 2019-10-08

Barrier Sleeves

Applicant Ivoclar Vivadent, AG

K-Number K191448

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HSX 2019-10-08

Bodycad Unicompartmental Knee System

Applicant Bodycad Laboratories, Inc.

K-Number K191150

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