Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

EOQ 2025-03-14

Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)

Applicant Shenzhen Sanping Image Technology Co., Ltd.

K-Number K242010

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EBF 2025-03-14

Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)

Applicant Kettenbach GmbH & Co. KG

K-Number K250267

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JAK 2025-03-14

BodyTom 64

Applicant Neurologica Corporation, A Subsidiary of Samsung

K-Number K242811

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EIH 2025-03-14

Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K250025

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FPA 2025-03-14

Solution Administration Sets

Applicant Baxter Healthcare Corporation

K-Number K243529

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OLZ 2025-03-14

DeepRESP

Applicant Nox Medical Ehf

K-Number K241960

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KRD 2025-03-14

Ruby XL System

Applicant Penumbra, Inc.

K-Number K250079

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LXC 2025-03-13

MY01 Continuous Compartmental Pressure Monitor

Applicant MY01, Inc.

K-Number K242997

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GEH 2025-03-13

CryoFreeze Wart and Skin Tag Remover

Applicant Cryosurgery, Inc.

K-Number K243487

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MCW 2025-03-13

Turbo-Elite Laser Atherectomy Catheter

Applicant Spectranetics

K-Number K250385

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QEW 2025-03-13

FlowTriever2 Catheter

Applicant Inari Medical, Inc.

K-Number K250088

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OWB 2025-03-13

Ziehm Vision FD

Applicant Ziehm Imaging GmbH

K-Number K243735

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