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

OVD 2023-04-21

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System

Applicant Kyocera Medical Technologies, Inc.

K-Number K230808

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OLO 2023-04-21

Anatase Spine Surgery Navigation System

Applicant Remex Medical Corp.

K-Number K230783

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DXN 2023-04-21

CONNEQT PULSE

Applicant Atcor Medical

K-Number K221742

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GDW 2023-04-21

AEON Endoscopic Stapler

Applicant Lexington Medical, Inc.

K-Number K222210

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ONF 2023-04-21

Intense Pulsed Light Treatment System

Applicant Shangdong Huamei Technology Co., Ltd.

K-Number K230816

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KRO 2023-04-21

Modular Rotating Hinge Knee Systems and Compatible Components

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K223069

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SBF 2023-04-21

Knee+

Applicant Pixee Medical

K-Number K230789

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IYN 2023-04-21

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K230084

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GEX 2023-04-21

OmniGuide RFID Surgical Laser Fibers

Applicant Omni-Guide Holdings, Inc.

K-Number K230819

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LLZ 2023-04-21

EzDent Web

Applicant Ewoosoft Co., Ltd.

K-Number K230468

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QIH 2023-04-21

ViewFinder Software Version 1.1

Applicant Elaitra, Ltd.

K-Number K223501

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HRX 2023-04-21

Kyphoplasty Balloon System

Applicant OK Medinet Korea Co., Ltd.

K-Number K221142

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