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

MRW 2022-10-05

FaSet Fixation System

Applicant Dio Medical Corporation

K-Number K222515

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NXC 2022-10-05

ClearCorrect System

Applicant Clearcorrect, LLC

K-Number K220140

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LON 2022-10-05

Colibrí System

Applicant Copan Wasp Srl

K-Number K220546

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MAI 2022-10-05

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II

Applicant Arthrex, Inc.

K-Number K221128

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FGB 2022-10-05

Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K222737

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BXQ 2022-10-05

VISIONAIR

Applicant Pacificmd Biotech, LLC

K-Number K221892

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LYX 2022-10-05

Cornisol

Applicant Aurolab

K-Number K221759

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GJS 2022-10-05

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

Applicant Coagusense, Inc.

K-Number K212779

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KFF 2022-10-04

HemosIL Liquid Anti-Xa

Applicant Instrumentation Laboratory CO

K-Number K213464

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QEW 2022-10-04

INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)

Applicant Penumbra, Inc.

K-Number K220683

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CAF 2022-10-04

Hailie Sensor NF0107 & NF0108

Applicant Adherium (Nz), Ltd.

K-Number K221994

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NKB 2022-10-04

CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K221646

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