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

OVK 2025-12-16

ADVIA Centaur Cytokeratin Fragment 21-1

Applicant Fujirebio Diagnostics,Inc.

K-Number K250925

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BZD 2025-12-15

SleepRes PAP System

Applicant Sleepres, Inc.

K-Number K251770

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LKF 2025-12-15

FemVue® Controlled Saline-Air Device (FSA-300)

Applicant Femasys, Inc.

K-Number K253403

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DYB 2025-12-15

V•Stick™ Vascular Access Set

Applicant Argon Medical Devices, Inc.

K-Number K253741

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NUC 2025-12-15

Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)

Applicant Foshan Pingchuang Medical Technology Co., Ltd.

K-Number K252935

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OLO 2025-12-15

Paradigm System

Applicant Proprio, Inc.

K-Number K252950

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KRO 2025-12-15

Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K252898

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KRD 2025-12-15

Tembo Embolic System

Applicant Instylla, Inc.

K-Number K253677

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OLI 2025-12-15

Erchonia CLX (Model # CFL)

Applicant Erchonia Corporation

K-Number K252574

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NAY 2025-12-15

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K252675

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QSY 2025-12-15

MFUSE (MS001)

Applicant Machina Medical, Inc.

K-Number K250319

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NQQ 2025-12-15

HyperVue™ Imaging System - Integrated

Applicant Spectrawave, Inc.

K-Number K253101

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