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

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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OLO 2025-04-25

Mako Total Knee Application (3.0); Hybrid Tip Pointer

Applicant Mako Surgical Corp.

K-Number K250608

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LXB 2025-04-25

contact forte Alpha

Applicant Bhm-Tech Produktionsgesellschaft Mbh

K-Number K243041

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GEX 2025-04-24

CO2 Laser System (CO2 Laser SST-L23)

Applicant Zhuozhou Summer Star Technologies Co., Ltd.

K-Number K250183

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MYN 2025-04-24

Lung AI (LAI001)

Applicant Exo, Inc.

K-Number K243239

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KNW 2025-04-24

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

Applicant SurGenTec, LLC

K-Number K243945

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DYB 2025-04-24

PeriCross™ Epicardial Access Kit

Applicant Circa Scientific, Inc.

K-Number K243954

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DXN 2025-04-24

Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K-Number K250116

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