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

LPL 2026-02-13

DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal

Applicant Alcon Laboratories, Inc.

K-Number K254052

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KPS 2026-02-13

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K253564

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GEH 2026-02-13

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)

Applicant Medinice S.A.

K-Number K251928

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DXT 2026-02-13

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)

Applicant Bayer Medical Care, Inc.

K-Number K252891

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DXQ 2026-02-13

NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)

Applicant Shenzhen Best Electronics Co., Ltd.

K-Number K253089

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HGX 2026-02-13

Wearable Breast Pump (Model W12)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K252420

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KWQ 2026-02-12

Lumbar Spine Truss System - Plating Solution (LSTS-PS)

Applicant 4Web, Inc.

K-Number K253201

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FMK 2026-02-12

Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K252490

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HRS 2026-02-12

Wrist Fracture System

Applicant Met One Technologies, LLC

K-Number K251732

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OWN 2026-02-12

IMAGE1 (TC400US); X-to-4U Adapter (TC040)

Applicant Karl Storz SE & CO. KG

K-Number K253972

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CEM 2026-02-12

ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions

Applicant Roche Diagnostics

K-Number K253491

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CFR 2026-02-12

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

Applicant Roche Diagnostics

K-Number K253490

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