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

FMK 2025-01-13

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus

Applicant Hlb Co., Ltd. Healthcare

K-Number K243533

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JWH 2025-01-13

Initia Knee System

Applicant Kyocera Medical Technologies, Inc.

K-Number K243295

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SBF 2025-01-13

ARVIS® Shoulder

Applicant Kico Knee Innovation Company Pty, Ltd.

K-Number K243950

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FMK 2025-01-13

LetsGetChecked Impress

Applicant Privapath Diagnostics Ltd (Dba Letsgetchecked)

K-Number K242680

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QPC 2025-01-13

AAMI Level 4 Protective; Gown

Applicant Azac Group

K-Number K242689

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NOU 2025-01-13

Vivo 45 LS

Applicant Breas Medical AB

K-Number K233452

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HIF 2025-01-13

High Flow Insufflation Unit (UHI-4)

Applicant Olympus Medical Systems Corporation

K-Number K243527

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DXN 2025-01-13

Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)

Applicant Joytech Healthcare Co. , Ltd.

K-Number K241431

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LPH 2025-01-13

Pantheon Proximal Femur Reconstruction (PFR) System

Applicant Adler Ortho S.P.A

K-Number K241059

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LPL 2025-01-13

Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric

Applicant Alcon Laboratories, Inc.

K-Number K243909

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LCJ 2025-01-12

Mentor CPX 4 PLUS Enhance Breast Tissue Expander

Applicant Mentor Worldwide, LLC

K-Number K243836

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ITI 2025-01-11

Electric Wheelchair (YE200)

Applicant Shenzhen Yattll Industry Co., Ltd.

K-Number K241641

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