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

GXI 2025-01-23

RF Cannula

Applicant Shanghai Samedical & Plastic Instruments Co., Ltd.

K-Number K241367

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INI 2025-01-23

Mobility Scooter (S-01); Mobility Scooter (S-02)

Applicant Zhejiang Seedream Medical Equipment Co., Ltd.

K-Number K242714

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EOQ 2025-01-23

MONARCH Platform (MON-000008)

Applicant Auris Health, Inc.

K-Number K243219

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MAX 2025-01-23

ProLift Pivot Expandable Spacer System

Applicant Life Spine, Inc.

K-Number K243668

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LLZ 2025-01-23

CephNinja

Applicant Cyncronus, LLC

K-Number K241819

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DXN 2025-01-23

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050

Applicant Murata Vios, Inc.

K-Number K241728

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QIH 2025-01-23

TeraRecon Aorta.CT (1.1.0)

Applicant Terarecon,Inc.

K-Number K243158

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FGB 2025-01-22

Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)

Applicant Hunan Endoso Life Technology Co., Ltd.

K-Number K241956

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JDW 2025-01-22

XT3 System

Applicant Biodynamik, Inc.

K-Number K241357

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NEW 2025-01-22

Suture-TOOL System

Applicant Suturion AB

K-Number K242835

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ONB 2025-01-22

ZeroClear Bag Access (423100)

Applicant Epic Medical Pte. , Ltd.

K-Number K243976

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GEI 2025-01-22

Reverso Pro System

Applicant Indiba S. A. U.

K-Number K243139

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