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

FBN 2023-02-16

Single-use Video Pancreaticobiliary Scope, PB Digital Controller

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K221784

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DQK 2023-02-16

CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4

Applicant Biosense Webster, Inc.

K-Number K223733

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KPE 2023-02-16

Disposable Infusion Bag for Parenteral Nutrition

Applicant Beijing L&Z Medical Technology Development Co., Ltd.

K-Number K222622

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IOR 2023-02-16

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X

Applicant Panthera AB

K-Number K220698

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JDR 2023-02-16

JAWS Nitinol Staple System

Applicant Paragon 28, Inc.

K-Number K223056

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EBG 2023-02-16

PMMA Blocks for Dental Use

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K223477

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LFL 2023-02-16

Sonopet 1Q 3 7cm 1Q Large

Applicant Stryker Corporation

K-Number K223770

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FYA 2023-02-16

Surgical Gown

Applicant Bayteks Teknik Tekstil San. VE Tic. A.S.

K-Number K213844

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LIT 2023-02-16

Passeo-35 Xeo Peripheral Dilatation Catheter

Applicant Biotronik, Inc.

K-Number K222065

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FMI 2023-02-15

Verisafe Safety sterile needles

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K222271

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LOX 2023-02-15

SC HONKYTONK PTCA Balloon Dilatation Catheter

Applicant Sino Medical Sciences Technology, Inc.

K-Number K223022

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MQB 2023-02-15

Digital Radiography CXDI-CS01

Applicant Canon, Inc.

K-Number K230175

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