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

QIH 2026-03-30

AiORTA - Plan v2.0

Applicant ViTAA Medical Solutions, Inc.

K-Number K254207

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LZO 2026-03-30

implantcast Packaging System Update

Applicant Implantcast GmbH

K-Number K260037

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MOL 2026-03-30

Sagami Original 002 Polyurethane Male Condom

Applicant Mayer Laboratories

K-Number K252158

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ODP 2026-03-30

Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System

Applicant Spectrum Spine

K-Number K252240

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EIH 2026-03-30

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Applicant Bloomden Bioceramics (HuNan) Co., Ltd.

K-Number K260370

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SAT 2026-03-28

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

Applicant Anumana, Inc.

K-Number K252360

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GEX 2026-03-28

CO2 Laser System

Applicant Sanhe Meditech Co., Ltd.

K-Number K260257

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PBF 2026-03-27

MedCAD® AccuStride™ System

Applicant Medcad

K-Number K252064

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QKB 2026-03-27

Contour ProtégéAI+

Applicant Mim Software, Inc.

K-Number K253270

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KWQ 2026-03-27

VyPlate™ Anterior Cervical Plate System

Applicant Vy Spine, LLC

K-Number K260697

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LLZ 2026-03-27

ARTICOR planner

Applicant Artiness S.R.L

K-Number K252195

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FAJ 2026-03-27

Strauss Surgical cystoscope, hysteroscope and accessories Instruments

Applicant American Medical Endoscopy, Inc.

K-Number K260271

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