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

HHW 2026-01-20

Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes

Applicant Cooper Surgical

K-Number K253698

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DQK 2026-01-18

CARTO™ 3 EP Navigation System V9.0 with PIU Plus

Applicant Biosense Webster, Inc.

K-Number K254085

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DSA 2026-01-18

Baylis Connector Cable

Applicant Baylis Medical Technologies, Inc.

K-Number K254114

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LOX 2026-01-17

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

Applicant Medtronic, Ireland

K-Number K251970

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JXI 2026-01-17

NeuroSpan Bridge

Applicant Auxilium Biotechnologies, Inc.

K-Number K253363

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SGZ 2026-01-16

SOLIUS PRO UVB Light Panel

Applicant Solius Labs, Inc.

K-Number K252960

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MRW 2026-01-16

Ion-C

Applicant SurGenTec, LLC

K-Number K251714

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LXC 2026-01-16

MY01 Continuous Compartmental Pressure Monitor

Applicant MY01, Inc.

K-Number K251900

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MYN 2026-01-16

qXR-Detect

Applicant Qure.Ai Technologies

K-Number K251934

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NGX 2026-01-16

CoolTone

Applicant Zimmer Medizinsysteme GmbH

K-Number K253408

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NAY 2026-01-16

da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator

Applicant Intuitive Surgical, Inc.

K-Number K253556

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LCJ 2026-01-16

Natrelle 133S Tissue Expanders

Applicant AbbVie

K-Number K254126

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