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

OWB 2023-12-14

ARTIS icono (VE30A)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K230950

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KYJ 2023-12-14

Ascension Silicone MCP; Ascension Silicone PIP

Applicant Ascension Orthopedics, Inc.

K-Number K233670

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OHV 2023-12-14

SofWave System

Applicant Sofwave Medical, Ltd.

K-Number K232455

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CBI 2023-12-14

Disposable Endobronchial Blocker Tube

Applicant Shenzhen Insighters Medical Technology Co., Ltd.

K-Number K232580

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DRE 2023-12-14

VersaCross Connect Transseptal Dilator

Applicant Baylis Medical Company, Inc.

K-Number K233647

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NBL 2023-12-14

C50

Applicant Sopro

K-Number K223470

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OLO 2023-12-13

Kalitec Navigated Instrument System

Applicant Kalitec Direct, LLC Doing Business AS Kalitec Medical

K-Number K232572

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DQK 2023-12-13

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K231870

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QTT 2023-12-13

SaliPen

Applicant Saliwell , Ltd.

K-Number K232063

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ITX 2023-12-13

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K231666

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KLE 2023-12-13

CLEARFIL Universal Bond Quick 2

Applicant Kuraray Noritake Dental, Inc.

K-Number K231039

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CFN 2023-12-13

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K233663

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