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

GEI 2026-02-11

CURIS II RF Generator (REF 360100-05)

Applicant Sutter Medizintechnik GmbH

K-Number K251813

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OUR 2026-02-11

iFuse INTRA Ti Implant System

Applicant SI-BONE, Inc.

K-Number K253488

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OWB 2026-02-11

ArmSure Fluoroscopic Positioning System

Applicant Savfe Co. , Ltd.

K-Number K251992

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SHE 2026-02-11

Delivery Date AI

Applicant Ultrasound AI

K-Number DEN250007

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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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