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

DXN 2025-07-16

Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603)

Applicant Cemho Medical Technology (Guangdong) Co., Ltd.

K-Number K251102

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LNH 2025-07-16

uMR 680

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K243397

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NQQ 2025-07-16

HyperVue Software

Applicant Spectrawave, Inc.

K-Number K251198

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ODC 2025-07-16

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)

Applicant Olympus Medical Systems Corporation

K-Number K250949

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NAY 2025-07-16

da Vinci Surgical System (IS5000)

Applicant Intuitive Surgical, Inc.

K-Number K251202

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DXQ 2025-07-15

Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)

Applicant Unimed Medical Supplies, Inc.

K-Number K251045

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LLZ 2025-07-15

AV Viewer

Applicant Philips Medical Systems Nederland B.V.

K-Number K250181

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KXK 2025-07-15

IsoSphere

Applicant Isoaid, LLC

K-Number K242818

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QYE 2025-07-15

Tempus ECG-Low EF

Applicant Tempus AI, Inc.

K-Number K250119

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QUW 2025-07-15

Jewel Soft Tissue Reinforcement Device (102-6005)

Applicant Xiros Limited

K-Number K242237

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OXH 2025-07-15

Kerecis SurgiBind (50241)

Applicant Kerecis Limited

K-Number K251844

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HGX 2025-07-15

Thrive 2-in-1 Breast Pump (Model P3)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K250350

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