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

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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QFM 2023-03-17

Viz AAA

Applicant Viz. Ai, Inc.

K-Number K223443

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PCH 2023-03-16

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

Applicant Biofire Diagnostics, LLC

K-Number K230404

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NAY 2023-03-16

Senhance Surgical System

Applicant Asensus Surgical, Inc.

K-Number K223095

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OLU 2023-03-16

iSyncBrain©-C

Applicant iMediSync, Inc.

K-Number K222838

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OBP 2023-03-16

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+

Applicant Magstim Company, Ltd.

K-Number K223154

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