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

KGN 2026-06-24

Endoform Dermal Template

Applicant Aroa Biosurgery , Ltd.

K-Number K260669

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ITI 2026-06-24

Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)

Applicant Shanghai Waylong Intelligent Technology Co.,Ltd

K-Number K260937

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FRO 2026-06-24

Microdacyn Wound Irrigation Solution

Applicant Sonoma Pharmaceuticals, Inc.

K-Number K261023

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EZD 2026-06-24

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)

Applicant Hangzhou Jimushi Meditech Co., Ltd.

K-Number K260394

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FET 2026-06-24

HD Camera Head OLYMPUS CH-S200-08-LB

Applicant Olympus Medical Systems Corporation

K-Number K261260

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JAK 2026-06-24

Enhanced Boundary for PCCT

Applicant Ge Medical Systems, LLC

K-Number K253560

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FLE 2026-06-24

AMSCO 700 Steam Sterilizer

Applicant STERIS Corporation

K-Number K261055

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KRD 2026-06-24

Concerto Versa™ Detachable Coil

Applicant Medtronic, Inc.

K-Number K261866

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FGE 2026-06-24

Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K253393

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OMP 2026-06-24

ConvaVAC™ Negative Pressure Wound Therapy System

Applicant Convatec Limited, Gdc Building

K-Number K253263

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OMB 2026-06-24

Ceribell Neurology Review Software

Applicant Ceribell, Inc.

K-Number K260998

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LZA 2026-06-24

Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution

Applicant Sw Technologies, Inc.

K-Number K252117

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