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

JZO 2024-08-09

Access TPO Antibody

Applicant Beckman Coulter, Inc.

K-Number K240469

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GAT 2024-08-09

HyperSuture All Blue Extension Line

Applicant Threadstone, LLC

K-Number K241376

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BTT 2024-08-08

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K234058

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LLZ 2024-08-08

SynthVISION 1.0.0

Applicant Synthesis Health Intelligence, Inc.

K-Number K240724

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ELC 2024-08-08

OdneClean

Applicant Odne AG

K-Number K233844

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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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