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

LRK 2025-10-22

Mandibular Advancement Device L07

Applicant Dcstar, Inc.

K-Number K251628

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QIH 2025-10-22

ANDI 2.0

Applicant Imeka Solutions, Inc.

K-Number K252298

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OBJ 2025-10-22

XC11 ICE System, USA

Applicant Yorlabs, Inc.

K-Number K250955

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NKB 2025-10-21

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

Applicant Astura Medical

K-Number K252346

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PBF 2025-10-21

Fine TTO

Applicant Bodycad Laboratories, Inc.

K-Number K250394

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MBI 2025-10-21

Aevumed FASE Suture Anchor

Applicant Aevumed, Inc.

K-Number K253040

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DYB 2025-10-21

Introducer Sheath Set

Applicant Cardiocycle Medical(Suzhou) Co., Ltd.

K-Number K251838

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HAW 2025-10-21

NeuroAlign software

Applicant Medivis, Inc.

K-Number K231897

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FGE 2025-10-21

Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)

Applicant Olympus Medical Systems Corporation

K-Number K250409

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DQK 2025-10-21

HemoSphere Stream Module

Applicant Edwards Lifesciences

K-Number K253034

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ONB 2025-10-21

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

Applicant Simplivia Healthcare , Ltd.

K-Number K253033

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NKB 2025-10-21

TriALTIS Spine System

Applicant Medos International SARL

K-Number K253249

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