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 2025-10-07

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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BTR 2025-10-06

Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)

Applicant Covidien, LLC

K-Number K250173

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LLZ 2025-10-03

HPACS

Applicant Healthhub

K-Number K250039

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GAM 2025-10-03

PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)

Applicant Internacional Farmacéutica S.A DE C.V

K-Number K252820

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FGB 2025-10-03

Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K252806

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GCJ 2025-10-03

Revolve Surgical System

Applicant Revolve Surgical, Inc.

K-Number K243968

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NAY 2025-10-03

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K251426

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