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

FRN 2024-05-17

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets

Applicant Zevex, Inc.

K-Number K232793

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KWQ 2024-05-17

ARENAL Anterior Cervical Plate System

Applicant Effortmed, LLC

K-Number K240935

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QUQ 2024-05-17

Kahook Dual Blade Glide (KDB Glide)

Applicant New World Medical, Inc.

K-Number K220891

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HHW 2024-05-17

Yoni.Fit Bladder Support

Applicant Watkins-Conti Products, Inc.

K-Number K232525

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KWQ 2024-05-17

icotec Anterior Cervical Plate System

Applicant Icotec AG

K-Number K233215

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MUJ 2024-05-17

Radiance V5

Applicant Gmv Soluciones Globales Internet S.A.U.

K-Number K233236

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LKD 2024-05-17

Sentec Digital Monitoring System (SDMS) tCOM+

Applicant Sentec AG

K-Number K232516

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OBO 2024-05-17

CIRRUS HD-OCT Model 6000

Applicant Carl Zeiss Meditec, Inc.

K-Number K233933

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ONF 2024-05-17

Intense Pulsed Light System (ST-690)

Applicant Smedtrum Medical Technology Co., Ltd.

K-Number K240482

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DRC 2024-05-17

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)

Applicant Pressure Products Medical Device Manufacturing, LLC

K-Number K241042

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SBC 2024-05-17

DentalMonitoring

Applicant Dental Monitoring Sas

K-Number DEN230035

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QIH 2024-05-17

uOmnispace.CT

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K233209

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