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

DRS 2023-03-17

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes

Applicant Merit Medical Pte. , Ltd.

K-Number K221782

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HCC 2023-03-17

Prism

Applicant Graymatters Health , Ltd.

K-Number K222101

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LDJ 2023-03-17

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT

Applicant Healgen Scientific,, LLC

K-Number K223162

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EBI 2023-03-17

Denture Base Resin

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K230115

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GYD 2023-03-17

NeuroRPM

Applicant New Touch Digital, Inc.

K-Number K221772

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JWH 2023-03-17

EMPOWR Stem Extender, 50mm

Applicant Encore Medical, L.P Dba Enovis

K-Number K230441

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QOF 2023-03-17

Simplexa COVID-19 & Flu A/B Direct

Applicant Diasorin Molecular, LLC

K-Number K220963

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HRS 2023-03-17

LOQTEQ® VA Elbow Plates 2.7/3.5 System

Applicant Aap Implantate AG

K-Number K230141

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HAW 2023-03-17

MagVenture TMS Atlas Neuro Navigation System

Applicant Tonica Elektronik A/S

K-Number K221544

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DCN 2023-03-17

RCRP Flex reagent cartridge

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K221119

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DRG 2023-03-17

Alio

Applicant Alio, Inc.

K-Number K223073

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MTD 2023-03-17

Ablacath Mapping Catheter

Applicant Ablacon, Inc.

K-Number K223666

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