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

OVE 2026-08-21

Pisces-SC Standalone Cervical Interbody System

Applicant Osseus Fusions Systems, LLC

K-Number K261882

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OWB 2026-08-21

uAngio AVIVA CX

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K253726

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SAT 2026-08-21

Tempus ECG-PH

Applicant Tempus AI, Inc.

K-Number K253699

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QEW 2026-08-21

Artix™ MT;Artix™ Thin-Walled Sheath

Applicant Inari Medical, Inc.

K-Number K262538

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MOD 2026-08-20

Valence InVent Xtend™ (CVG-4101-VXA)

Applicant Convergence Medical Sciences , Ltd.

K-Number K253807

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SAB 2026-08-20

MIRA Surgical System

Applicant Virtual Incision

K-Number K260817

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HGX 2026-08-20

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))

Applicant Guangdong Youmeng Electrical Technology Co., Ltd.

K-Number K261298

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MHX 2026-08-20

Infinity® Acute Care System (IACS) – VG8.1

Applicant Draeger Medical Systems, Inc.

K-Number K260579

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JTN 2026-08-20

HardyDisk AST Tebipenem 10µg (TBP10)

Applicant Hardy Diagnostics

K-Number K262113

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MAX 2026-08-20

SCALA® TL

Applicant Spineart SA

K-Number K261049

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GYD 2026-08-20

Kneu Platform (V2)

Applicant Kneu Health Digital , Ltd.

K-Number K262515

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OLO 2026-08-20

Remex Spine Surgery Navigation - Universal Instruments

Applicant Remex Medical Corp.

K-Number K262506

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