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

NXC 2024-02-22

MESHEET

Applicant Dentis Co., Ltd.

K-Number K233544

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JAK 2024-02-22

Revolution Ascend Sliding

Applicant Ge Hangwei Medical Systems Co., Ltd.

K-Number K233749

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GEI 2024-02-22

Oligio X

Applicant Wontech Co., Ltd.

K-Number K240313

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MXA 2024-02-22

Vivatmo pro

Applicant Bosch Healthcare Solutions GmbH

K-Number K233775

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ITH 2024-02-22

Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac

Applicant Ergo-Flex Technologies, LLC

K-Number K214037

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QRY 2024-02-21

X-Guide Surgical Navigation System

Applicant X-Nav Technologies, LLC

K-Number K232148

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HQD 2024-02-21

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)

Applicant Visionary Optics, LLC

K-Number K233325

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IYN 2024-02-21

HD60 Series Ultrasound Diagnostic System

Applicant Qingdao Hisense Medical Equipment Co., Ltd.

K-Number K233439

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BTY 2024-02-21

Pulmonary Function Tester, Model: A9

Applicant Guangzhou Homesun Medical Technology Co., Ltd.

K-Number K231561

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PHX 2024-02-21

BLUEPRINT™ Patient Specific Instrumentation

Applicant Tornier S.A.S.

K-Number K232265

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MBI 2024-02-21

ProCinch, QuadCinch

Applicant Riverpoint Medical

K-Number K240194

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DWJ 2024-02-21

Cocoon Convective Warming System, Model CWS7000

Applicant Care Essentials Pty, Ltd.

K-Number K232502

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