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

NAY 2025-12-02

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K252069

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QIH 2025-12-02

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Applicant Mighty Oak Medical

K-Number K252103

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NGT 2025-12-02

0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe

Applicant Becton, Dickinson and Company

K-Number K250884

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FBK 2025-12-02

Disposable Endoscopic Injection Needles

Applicant Changzhou New Med Micro-Medtech Co., Ltd.

K-Number K252021

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SGT 2025-12-02

Aura Wave

Applicant Aura Wellness, LLC

K-Number K250896

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KPS 2025-12-01

Cartesion Prime (PCD-1000A/3) V10.21

Applicant Canon Medical Systems Corporation

K-Number K251370

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DQA 2025-12-01

Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)

Applicant Unimed Medical Supplies, Inc.

K-Number K251691

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OLI 2025-12-01

Led Light Phototherapy Bed (Pro 450/ GY-680A)

Applicant Shenzhen Suyzeko Limited.

K-Number K252786

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DQA 2025-12-01

Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)

Applicant Unimed Medical Supplies, Inc.

K-Number K251696

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PEK 2025-12-01

Minuteman® G6 MIS Fusion Plate

Applicant Spinal Simplicity, LLC

K-Number K253250

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KWT 2025-12-01

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants

Applicant Exactech, Inc.

K-Number K250713

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DSA 2025-12-01

IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)

Applicant Drägerwerk AG & Co. KGaA

K-Number K252827

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