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

NAY 2023-05-12

da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)

Applicant Intuitive Surgical, Inc.

K-Number K231224

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KYF 2023-05-12

Ahmed® Glaucoma Valve Model FP7

Applicant New World Medical, Inc.

K-Number K230975

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BTA 2023-05-12

SOMAVAC® 100 Sustained Vacuum System

Applicant Somavac Medical Solutions, Inc.

K-Number K231063

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LLZ 2023-05-12

iTFlow

Applicant Cardio Flow Design, Inc.

K-Number K222854

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KYF 2023-05-12

Ahmed® Glaucoma Valve Model FP8

Applicant New World Medical, Inc.

K-Number K231051

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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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