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

NHA 2023-05-12

IU Implant System Abutment

Applicant Warantec Co., Ltd.

K-Number K221969

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EBG 2023-05-12

PMMA BLOCK

Applicant Huliang(Shanghai) Bio-Tech Co., Ltd.

K-Number K223706

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QWP 2023-05-12

Waypoint GPS

Applicant Waypoint Orthopedics, Inc.

K-Number K222106

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LLZ 2023-05-11

SubtleMR (2.3.x)

Applicant Subtle Medical, Inc.

K-Number K223623

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MQL 2023-05-11

CryoX Vitrification Freeze Kit / Thaw Kit

Applicant Zhejiang Horizon Medical Technology Co., Ltd.

K-Number K223265

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IYE 2023-05-11

ExacTrac Dynamic 1.1.2

Applicant Brainlab AG

K-Number K231052

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KDI 2023-05-11

FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K220721

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OWY 2023-05-11

Regeneten Bioinductive Implant

Applicant Smith and Nephew, Inc.

K-Number K222501

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KTI 2023-05-11

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve

Applicant Ga Health Company Limited

K-Number K230280

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JDR 2023-05-11

JAWS Nitinol Staple System

Applicant Paragon 28, Inc.

K-Number K230550

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NPK 2023-05-11

OpenTex

Applicant Purgo Biologics, Inc.

K-Number K222549

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FLL 2023-05-10

Digital Thermometer (Model QT001)

Applicant Shen Zhen Rong Feng Technology Co., Ltd.

K-Number K223044

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