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 2024-12-10

Elos Accurate® Hybrid Base

Applicant Elos Medtech Pinol A/S

K-Number K242025

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MWI 2024-12-10

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)

Applicant Analog Devices

K-Number K243216

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DZE 2024-12-10

Straumann® PURE Ceramic Implants

Applicant Institut Straumann AG

K-Number K241391

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DQX 2024-12-10

Prelude Small O.D. Introducer Guide Wire

Applicant Merit Medical Systems, Inc.

K-Number K241521

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ITI 2024-12-10

Empulse M90

Applicant Concourse Assistive Technology Pty, Ltd.

K-Number K242327

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GEI 2024-12-10

Aerin Console

Applicant Aerin Medical, Inc.

K-Number K242630

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IYN 2024-12-10

V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K242511

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QIH 2024-12-10

IRISeg

Applicant Intuitive Surgical, Inc.

K-Number K242461

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PSY 2024-12-10

Philips IntelliSite Pathology Solution 5.1

Applicant Philips Medical Systems Nederland B.V.

K-Number K242848

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HKI 2024-12-09

Verily Numetric Retinal Camera

Applicant Verily Life Sciences, LLC

K-Number K242508

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QKB 2024-12-09

AutoContour (Model RADAC V4)

Applicant Radformation, Inc.

K-Number K242729

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IZL 2024-12-09

Digital Radiography System (ManntiX B, ManntiX K)

Applicant Shenzhen Browiner Tech Co., Ltd.

K-Number K240841

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