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

QJP 2026-02-11

AXS Lift Intracranial Base Catheter

Applicant Stryker Neurovascular

K-Number K253032

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QIH 2026-02-11

AI4CMR v2.0

Applicant Ai4medimaging Medical Solutions S.A.

K-Number K252084

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QBP 2026-02-11

SteriHub™ Disinfecting Device and Protective Cover

Applicant 1World Vista Medical

K-Number K251592

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JDW 2026-02-10

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm

Applicant Biodynamik, Inc.

K-Number K260073

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LRX 2026-02-10

LANDR Contact LENS Case

Applicant Fourth Axis, LLC

K-Number K252175

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KDI 2026-02-10

multiFlux 130 (F00013123); multiFlux 160 (F00013124)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K252459

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KGN 2026-02-10

CollOvine™ Wound Powder

Applicant Ovigenex, LLC

K-Number K253140

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NKB 2026-02-10

Vulcan Spinal System

Applicant K2m, Inc.

K-Number K253545

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MOS 2026-02-10

GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only

Applicant Shenzhen RF Tech Co., Ltd.

K-Number K252179

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MJV 2026-02-10

Earflo (EF001)

Applicant Earflo, Inc.

K-Number K252751

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OVB 2026-02-10

SpaceOAR Vue System (SV-2101)

Applicant Boston Scientific Corporation

K-Number K260119

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NHA 2026-02-10

Solidex® Ti-Links and Screws

Applicant CreoDent Hudson Valley

K-Number K251515

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