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

FED 2025-04-11

Disposable ureteral access sheath

Applicant Shenzhen Trious Medical Technology Co., Ltd.

K-Number K243710

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QPF 2025-04-11

Canvas Dx

Applicant Cognoa, Inc.

K-Number K243558

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OLZ 2025-04-10

NEAT 001

Applicant Brain Electrophysiology Laboratory Company, LLC

K-Number K250058

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IYN 2025-04-10

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K250177

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OVE 2025-04-10

Tesera-k SC System

Applicant Kyocera Medical Technologies, Inc.

K-Number K242928

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HWC 2025-04-10

TriMed® Compression Screws

Applicant TriMed, Inc.

K-Number K243943

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HSB 2025-04-10

FitboneTM Trochanteric

Applicant Orthofix Srl

K-Number K250112

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KNT 2025-04-10

XNY Disposable Gastric Calibration Tube

Applicant Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

K-Number K250389

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LPH 2025-04-10

Initia T3 Acetabular Hemispherical Shell System

Applicant Kyocera Medical Technologies, Inc.

K-Number K242045

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KWQ 2025-04-10

Skyway Anterior Cervical Plate System

Applicant Kyocera Medical Technologies Inc. (KMTI)

K-Number K250486

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MQL 2025-04-10

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)

Applicant Jiangsu Ruifuda Medical Device Co., Ltd.

K-Number K242089

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LPL 2025-04-10

Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)

Applicant Vizionfocus, Inc.

K-Number K243953

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