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

FED 2025-10-07

Prodeon Urethral Sheath System

Applicant Prodeon Medical, Inc.

K-Number K252572

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GEI 2025-10-07

Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)

Applicant Olympus Medical Systems Corporation

K-Number K252150

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IMG 2025-10-07

Ultrasound Therapy Workstation (XMS-UET2)

Applicant Xemis Medical Technology (Shenzhen) Co., Ltd.

K-Number K244041

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NQQ 2025-10-07

deepLive (OSP12 + DMS)

Applicant Damae Medical

K-Number K252851

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KGE 2025-10-07

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)

Applicant Olympus Medical Systems Corporation

K-Number K250187

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GEI 2025-10-07

Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)

Applicant Acotec Scientific Co., Ltd.

K-Number K250688

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INI 2025-10-06

Folding Mobility Scooter (KD101)

Applicant Nanjing Kangni Smart Technology Co., Ltd.

K-Number K252502

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EXB 2025-10-06

Heylo System

Applicant Coloplast Corp.

K-Number K252140

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QIH 2025-10-06

BlineSlide

Applicant Deep Breathe, Inc.

K-Number K252007

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ITI 2025-10-06

Wheelchair (N817)

Applicant Zhejiang Topwe Tools Manufacturing Co.,Ltd

K-Number K251565

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NRY 2025-10-06

Tigertriever 17 Ultra Revascularization Device

Applicant Rapid Medical , Ltd.

K-Number K251603

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SGB 2025-10-06

PainChek (PainChek Adult)

Applicant Painchek Limited (Ltd.)

K-Number DEN240073

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