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

MHX 2026-01-09

Corvair Monza

Applicant AliveCor, Inc.

K-Number K252589

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SBF 2026-01-09

NextAR Hip Platform

Applicant Medacta International S.A.

K-Number K252847

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SAH 2026-01-09

Self-Forming Magnet (Flexagon Plus OTOLoc)

Applicant GI Windows, Inc.

K-Number K253550

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DXN 2026-01-09

Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)

Applicant Ningbo Ranor Medical Technology Co., Ltd.

K-Number K253142

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GFO 2026-01-09

HemosIL Silica Clotting Time

Applicant Instrumentation Laboratory (IL) Co.

K-Number K253957

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KPE 2026-01-09

KabiHelp® Uno; KabiHelp® Advance plus

Applicant Fresenius Kabi AG

K-Number K251139

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OXC 2026-01-09

ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)

Applicant Ethicon Endo-Surgery, LLC

K-Number K252906

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CGX 2026-01-09

Nova Allegro UACR Assay, Nova Allegro Analyzer

Applicant Nova Biomedical Corporation

K-Number K252206

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DXQ 2026-01-09

Disposable Neonatal NIBP Cuff (U1681S-C51N)

Applicant Unimed Medical Supplies, Inc.

K-Number K253964

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QQH 2026-01-09

iotaSOFT® Insertion System

Applicant Iotamotion, Inc.

K-Number K252339

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IYN 2026-01-08

LOGIQ Totus

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K253370

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FRO 2026-01-08

revyve® Antimicrobial Skin and Wound Cleanser

Applicant Kane Biotech, Inc.

K-Number K252759

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