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

BTM 2025-04-25

butterflyBVM

Applicant Compact Medical, Inc.

K-Number K243861

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DYB 2025-04-25

Prelude Wave Hydrophilic Sheath Introducer

Applicant Merit Medical Systems, Inc.

K-Number K250909

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JLW 2025-04-25

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

Applicant Siemens Healthcare Diagnostics

K-Number K243570

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GYD 2025-04-25

Neu Platform

Applicant Neuhealth Digital , Ltd.

K-Number K250153

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QLQ 2025-04-25

prodisc® L Instruments

Applicant Centinel Spine, LLC

K-Number K250554

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IRP 2025-04-25

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)

Applicant Shenzhen Urion Technology Co., Ltd.

K-Number K250046

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QPB 2025-04-25

PAL 7020 Console

Applicant Microaire Surgical Instruments, LLC

K-Number K244026

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GEI 2025-04-25

RFMagik Lite

Applicant Agnes Medical Co., Ltd.

K-Number K242469

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IYN 2025-04-25

Kosmos

Applicant EchoNous, Inc.

K-Number K242321

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QOF 2025-04-25

cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test

Applicant Roche Molecular Systems, Inc.

K-Number K243406

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KDI 2025-04-25

DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

Applicant Sorin Group Italia S.R.L.

K-Number K243264

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DQY 2025-04-25

Amulet Steerable Delivery Sheath

Applicant ABBOTT MEDICAL

K-Number K250426

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