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

LLZ 2025-10-08

ProKnow DS

Applicant Elekta Solutions AB

K-Number K251363

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OAS 2025-10-08

GT300; GT300-C

Applicant Genoray Co., Ltd.

K-Number K250060

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HWC 2025-10-08

MetaFore Small Screw System

Applicant Extremity Medical, LLC

K-Number K250536

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SET 2025-10-08

Elecsys Phospho-Tau (181P) Plasma

Applicant Roche Diagnostics

K-Number K252163

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KTI 2025-10-08

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01

Applicant Serpex Medical, Inc.

K-Number K252874

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GEX 2025-10-08

The Botticelli (Model: Athena)

Applicant Bellamia Technologies, Inc.

K-Number K251699

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FOZ 2025-10-08

BD Saf-T-Intima Subcutaneous Catheter System

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K251422

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HDB 2025-10-08

Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)

Applicant Clinical Innovations, LLC

K-Number K250298

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QIH 2025-10-07

AIAS Cephalon

Applicant Metamorphosis GmbH

K-Number K252214

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IYE 2025-10-07

TrueBeam, TrueBeam STX, Edge and VitalBeam

Applicant Varian Medical Systems, Inc.

K-Number K252948

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OUR 2025-10-07

Eminent Spine Posterior SI System

Applicant Eminent Spine

K-Number K250894

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LPL 2025-10-07

Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

Applicant St. shine Optical Co., Ltd.

K-Number K250364

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