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

OCC 2026-05-01

BioCode® Respiratory Pathogen Panel (RPP)

Applicant Applied BioCode, Inc.

K-Number K254139

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CGA 2026-05-01

ABL90 FLEX PLUS System

Applicant Radiometer Medicals Aps

K-Number K252488

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NDC 2026-05-01

EndoTool IV Cloud 1.0

Applicant Glooko, Inc.

K-Number K260910

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SAK 2026-04-30

Bayesian Health Sepsis Flagging Device

Applicant Bayesian Health, Inc.

K-Number K250680

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QQJ 2026-04-30

FSYX Ocular Pressure Adjusting Pump

Applicant Balance Ophthalmics, Inc.

K-Number K252455

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HRS 2026-04-30

OrthoPediatrics® Locking Cannulated Blade Plate System

Applicant OrthoPediatrics Corp.

K-Number K260323

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QIH 2026-04-30

Synapse 3D Base Tools (V7.2)

Applicant Fujifilm Corporation

K-Number K254189

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IRP 2026-04-30

Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)

Applicant Xiamen Weiyou Intelligent Technology Co., Ltd.

K-Number K253064

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GTY 2026-04-30

AllTest Strep A Rapid Test

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K260342

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QSY 2026-04-30

BloodSTOP iX Trauma Matrix (TM-iX-20)

Applicant Lifescience Plus, Inc.

K-Number K253017

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OWB 2026-04-30

Intelligent NR

Applicant Canon, Inc.

K-Number K252503

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QFG 2026-04-30

iLet ACE Pump

Applicant Beta Bionics, Inc.

K-Number K253976

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