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

DPS 2024-08-08

Masimo W1

Applicant Masimo Corporation

K-Number K240229

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DWE 2024-08-08

SMARxT Tubing and Connectors

Applicant LivaNova USA, Inc.

K-Number K233702

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QZB 2024-08-08

SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894

Applicant Aktormed GmbH

K-Number K233312

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QQU 2024-08-08

Luminopia

Applicant Luminopia, Inc.

K-Number K233720

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NXC 2024-08-08

Illusion Aligner Pro: Illusion Aligner FLX

Applicant Laxmi Dental Export Pvt., Ltd.

K-Number K233356

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QIH 2024-08-08

i2Contour

Applicant Mrimath, LLC

K-Number K233822

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OLO 2024-08-08

360CAS Knee

Applicant Kico Knee Innovation Company Pty, Ltd.

K-Number K242009

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MQC 2024-08-08

GR Resin System MSI

Applicant Pro3Dure Medical

K-Number K231775

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KPS 2024-08-08

Omni Legend

Applicant Ge Medical Systems Israel, Functional Imaging

K-Number K241665

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OSF 2024-08-08

HipXpert and HipInsight System

Applicant Surgical Planning Associates, Inc.

K-Number K233315

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GCJ 2024-08-07

Stellar Imaging System

Applicant Guangdong Optomedic Technologies, Inc.

K-Number K241530

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NGX 2024-08-07

SofWave System

Applicant Sofwave Medical, Ltd.

K-Number K241685

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