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

SEI 2026-03-13

Access anti-HBc IgM

Applicant Beckman Coulter, Inc.

K-Number K254059

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LNH 2026-03-13

Embrace Neonatal MRI System

Applicant Aspect Imaging, Ltd.

K-Number K254277

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FGE 2026-03-13

BARE Wireguided Balloon Dilation Catheter (1235)

Applicant GIE Medical

K-Number K253987

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GXP 2026-03-13

Permatage Flowable, Settable Bone Paste

Applicant Orthocon, Inc.

K-Number K253732

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JKA 2026-03-13

BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes

Applicant Becton, Dickinson and Company

K-Number K252040

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PCU 2026-03-13

Niti-S SPAXUS Stent

Applicant Taewoong Medical Co., Ltd.

K-Number K252648

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PBX 2026-03-13

Apollo Quattro (APQ-10M)

Applicant Weero Co., Ltd.

K-Number K253261

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FRO 2026-03-13

Promogran Prisma Collagen Matrix with ORC and Silver

Applicant Solventum Germany GmbH

K-Number K251999

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LLZ 2026-03-13

TheraSphere 360 Y-90 Management Platform

Applicant Boston Scientific Corporation

K-Number K260479

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DQY 2026-03-13

Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80

Applicant ABBOTT MEDICAL

K-Number K260499

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BTA 2026-03-13

Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)

Applicant Shenzhen Kingboom Technology Co., Ltd.

K-Number K260147

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PKL 2026-03-12

Taurus Clip

Applicant Taurus Endoscopy

K-Number K253734

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