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

EOQ 2024-09-24

Ion Endoluminal System (IF 1000)

Applicant Intuitive Surgical, Inc.

K-Number K242070

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BZD 2024-09-24

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System

Applicant Resmed Pty Ltd (Registration Number: 3004604967)

K-Number K234134

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MAX 2024-09-24

LumiVy Lumbar IBF System

Applicant Vy Spine, LLC

K-Number K233807

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QAS 2024-09-24

uAI Easy Triage ICH

Applicant Shanghai United Imaging Intelligence Co., Ltd.

K-Number K242292

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GEH 2024-09-24

Celsio Flexible Cryocatheter System

Applicant Endocision Technologies, Inc.

K-Number K240776

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MWI 2024-09-24

Happy Ring Health Monitoring System

Applicant Happy Health, Inc.

K-Number K240236

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OCX 2024-09-24

Aspiration Catheter (2189)

Applicant Hobbs Medical, Inc.

K-Number K241874

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QUO 2024-09-23

EchoGo Heart Failure (2.0)

Applicant Ultromics Limited

K-Number K240013

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LLZ 2024-09-23

EConsole2

Applicant DRTECH Corporation

K-Number K240243

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OHT 2024-09-23

IPL Hair Removal Device (BE932C, BE932D, BE932E)

Applicant Shenzhen Yang WO Electronic Co., Ltd.

K-Number K241834

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JWH 2024-09-23

Unity Total Knee System

Applicant Corin U.S.A. Limited

K-Number K241570

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QIH 2024-09-20

PIUR tUS Infinity

Applicant Piur Imaging GmbH

K-Number K240036

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