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

MWI 2026-10-16

Sensinel Cardiopulmonary Management (CPM) System

Applicant Analog Devices

K-Number K260801

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MED 2026-10-16

Endox High Level Disinfectant

Applicant Whiteley USA, Inc.

K-Number K254094

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JKA 2026-10-16

BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)

Applicant Becton, Dickinson and Company

K-Number K252344

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LGM 2026-10-16

Carecube Negative Pressure Isolation Chamber (1BY)

Applicant Carecubes, Inc.

K-Number K260180

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HGX 2026-10-16

MODO DUO Electric Pump (B11621, B11673)

Applicant Tomy International, Inc.

K-Number K261782

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JAK 2026-10-16

AVIEW Aorta Metrics

Applicant Coreline Soft Co., Ltd.

K-Number K260391

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QSZ 2026-10-16

Restrata

Applicant Acera Surgical, Inc.

K-Number K261245

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DQX 2026-10-16

Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)

Applicant Skycade Med Corporation

K-Number K260168

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EIH 2026-10-16

Amber Arte

Applicant Hass Corp.

K-Number K262523

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IYO 2026-10-16

Lilium one (USM330)

Applicant Lilium Otsuka Co., Ltd.

K-Number K260605

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DYB 2026-10-15

Giranel Guiding Sheath Set

Applicant Kossel Medtech (Suzhou) Co., Ltd.

K-Number K262674

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PSV 2026-10-15

Single-Use EBUS Balloon

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K261616

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