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

JOM 2022-10-20

PADnet Xpress

Applicant Collaborative Care Diagnostics, LLC, D.B.A. Biomedix

K-Number K220527

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NHA 2022-10-20

BTI Interna Dental Implant System UnicCa - Prosthetic Components

Applicant B.T.I. Biotechnology Institute, Sl.

K-Number K213106

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DXH 2022-10-20

V-Patch Cardiac Monitor

Applicant Shandong Corecare Technology Limited

K-Number K222842

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JAK 2022-10-20

AI-Rad Companion (Musculoskeletal)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K222361

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NAY 2022-10-20

da Vinci Firefly Imaging System

Applicant Intuitive Surgical, Inc.

K-Number K222827

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DSH 2022-10-20

eWave Monitor

Applicant Wearlinq, Inc.

K-Number K214073

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MQB 2022-10-20

Mercu 1717V

Applicant Iray Technology Taicang , Ltd.

K-Number K222886

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BTA 2022-10-20

Electric nasal aspirator

Applicant Shenzhen Xinlianfeng Technology Co.,Ltd

K-Number K222547

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DQY 2022-10-20

Houdini Cross Support Catheter

Applicant Cruzar Medsystems, Inc.

K-Number K213466

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GZL 2022-10-20

Evo® sEEG System

Applicant Neuroone Medical Technologies Corp.

K-Number K222404

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JDR 2022-10-20

Tyber Medical Staple Fixation System (various)

Applicant Tyber Medical, LLC

K-Number K221947

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QMV 2022-10-20

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

Applicant Biofire Defense, LLC

K-Number K220870

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