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

DXN 2021-04-01

Omron Model BP7900 Blood Pressure Monitor + EKG

Applicant Omron Healthcare, Inc.

K-Number K202228

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LNH 2021-04-01

Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K210340

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GEI 2021-04-01

Star RF Electrode, VIVA RF Electrode

Applicant Starmed Co., Ltd.

K-Number K203795

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LZO 2021-04-01

KOSMO Femoral Stem

Applicant B-One Ortho, Corp.

K-Number K202768

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DRY 2021-04-01

B-Capta

Applicant Livanova Deutschland, GmbH

K-Number K202154

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LYL 2021-04-01

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

Applicant Vuesonic, LLC

K-Number K210300

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IYN 2021-04-01

ACUSON Redwood Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K210743

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OLO 2021-04-01

TSolution One Total Knee Application

Applicant THINK Surgical, Inc.

K-Number K210668

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IZL 2021-04-01

Nanox Cart X-ray System

Applicant Nano-X Imaging , Ltd.

K-Number K203782

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DTZ 2021-04-01

AMG PMP Pediatric

Applicant Eurosets S.R.L

K-Number K202206

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LPL 2021-04-01

Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo

Applicant Largan Medical Co., Ltd.

K-Number K202129

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LLZ 2021-04-01

Simpleware ScanIP Medical

Applicant Synopsys (Northern Europe) , Ltd.

K-Number K203195

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