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

NRY 2026-05-20

Zenith Aspiration Catheter; Disposable Aspiration Tubing Set

Applicant Suzhou Zenith Vascular SciTech Limited

K-Number K252707

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GEI 2026-05-20

LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)

Applicant Lagis Enterprise Co., Ltd.

K-Number K253134

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INI 2026-05-20

Mobility Scooter (Air Carbon)

Applicant Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.

K-Number K260717

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HCG 2026-05-20

Numen™ Helia Coil Embolization System; NumenFR™ Detachment System

Applicant MicroPort NeuroTech (Shanghai) Co., Ltd.

K-Number K260351

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OHT 2026-05-20

IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)

Applicant Shenzhen Xiazhifeng Electronic Co., Ltd.

K-Number K260594

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JAQ 2026-05-20

MAASTRO Rectal Applicator Set

Applicant Varian Medical Systems

K-Number K252717

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DRT 2026-05-20

The Circadia C300 System (C300)

Applicant Circadia Health, Inc.

K-Number K261286

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JAK 2026-05-20

Aquilion ONE (TSX-308A/TSX-306A) V2.0

Applicant Canon Medical Systems Corporation

K-Number K253596

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LIT 2026-05-20

WAVE PTA Balloon Catheter

Applicant WAVE Medical AG

K-Number K260304

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MHX 2026-05-20

ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K260098

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DXN 2026-05-20

Blood Pressure Monitor (W06LT)

Applicant Shenzhen Jamr Technology Co., Ltd.

K-Number K253570

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NHN 2026-05-19

MR5 Activ Pro

Applicant Multi Radiance Medical, Inc.

K-Number K254024

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