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

GEX 2026-01-30

Boston PICO (Boston PICO)

Applicant Boston Aesthetics, Inc.

K-Number K251981

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GQG 2026-01-30

Clungene RSV Antigen Rapid Test

Applicant Hangzhou Clongene Biotech Co., Ltd.

K-Number K253318

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SCL 2026-01-30

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)

Applicant Asistan Medikal

K-Number K250983

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NHA 2026-01-29

EK MULTI ANGLED 30 ABUTMENT

Applicant Hiossen, Inc.

K-Number K251427

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KPO 2026-01-29

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K253462

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OUR 2026-01-29

Falco Fusion System

Applicant Mcnicoll Surgical, Inc.

K-Number K253611

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DJG 2026-01-29

Labcorp Fentanyl Urine Visual Test

Applicant Medtox Diagnostics, Inc.

K-Number K252684

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EZD 2026-01-29

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits

Applicant HR Healthcare

K-Number K251274

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IOR 2026-01-29

Manual Wheelchair (W50)

Applicant Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.

K-Number K253632

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QIH 2026-01-29

Surgical Reality Viewer

Applicant Medicalvr B.V.

K-Number K252091

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NHA 2026-01-29

Multi-Unit DAS System

Applicant Talladium España, SL

K-Number K243732

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GCJ 2026-01-29

Medical Shaver System (Morcellator) (YSB-IIIA)

Applicant Hangzhou Hawk Optical Electronic Instruments Co., Ltd.

K-Number K251923

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