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

LZA 2021-04-20

Disposable Nitrile Examination Gloves

Applicant Jiangsu Yanfang Medical Technology Co., Ltd.

K-Number K203805

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NKB 2021-04-20

M.U.S.T. Midline Cortical (MC) Screw System

Applicant Medacta International S.A.

K-Number K210427

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QKB 2021-04-20

Automatic Anatomy Recognition (AAR)

Applicant Quantitative Radiology Solutions, LLC

K-Number K203610

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OLO 2021-04-19

ROSA Partial Knee System

Applicant Orthosoft D/B/A Zimmer Cas

K-Number K210121

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NKB 2021-04-19

Goblin and Goblin LS Pedicle Screw Systems

Applicant Medynus, Inc.

K-Number K210420

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OOG 2021-04-19

Triathlon AS-1

Applicant Conformis, Inc.

K-Number K203421

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NUC 2021-04-19

Solevy Co. LLC Water-Based Personal Lubricant

Applicant Solevy Co., LLC

K-Number K203654

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ITI 2021-04-19

Karma Powered Wheelchair

Applicant Karma Medical Products Co., Ltd.

K-Number K202506

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MUJ 2021-04-19

AI Segmentation

Applicant Varian Medical Systems, Inc.

K-Number K203469

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MAI 2021-04-19

Arthrex SwiveLock Anchor

Applicant Arthrex, Inc.

K-Number K203495

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DZE 2021-04-19

Dentis s-Clean s-Line

Applicant Dentis Co., Ltd.

K-Number K210134

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DSB 2021-04-19

SOZO

Applicant ImpediMed Limited

K-Number K203473

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