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

NLH 2019-02-22

Reprocessed Response Diagnostic Electrophysiology Catheter

Applicant Innovative Health, LLC

K-Number K182488

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DXH 2019-02-22

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile

Applicant Cardiocomm Solutions, Inc.

K-Number K181310

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GWF 2019-02-22

The EPAD 2 System

Applicant Safeop Surgical, Inc.

K-Number K182542

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MQP 2019-02-22

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System

Applicant Choicespine

K-Number K183588

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MAX 2019-02-22

Altus Spine Interbody Fusion System

Applicant Altus Partners, LLC

K-Number K182406

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LNH 2019-02-22

EMMA 1.5T MRI System

Applicant Time Medical Limited

K-Number K183621

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EOQ 2019-02-22

FUJIFILM Ultrasonic Endoscope

Applicant Fujifilm Corporation

K-Number K182825

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OWN 2019-02-22

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes

Applicant Mauna Kea Technologies

K-Number K183640

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GEI 2019-02-22

Empower RF Catheter

Applicant Broncus Medical, Inc.

K-Number K183240

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FMZ 2019-02-22

Babyleo TN500

Applicant Dragerwerk AG & CO Kgaa

K-Number K182859

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LLZ 2019-02-22

IRIS 1.0 System

Applicant Intuitive Surgical

K-Number K182643

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LCX 2019-02-22

DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette

Applicant Runbio Biotech Co.,Ltd

K-Number K181551

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