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

MTD 2024-08-07

Sphere-9Dx Diagnostic Catheter (AFR-00009)

Applicant Medtronic

K-Number K233433

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DYB 2024-08-06

Abiomed 14Fr Low Profile Introducer Kit

Applicant Abiomed, Inc.

K-Number K241708

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KPR 2024-08-06

EOSedge

Applicant Eos Imaging

K-Number K233920

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LZA 2024-08-06

Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential

Applicant Comfort Rubber Gloves Industries Sdn. Bhd.

K-Number K241528

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QTZ 2024-08-06

myAblation Guide (VB80A)

Applicant Siemens Healthcare GmbH

K-Number K240796

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QIH 2024-08-05

AI Platform 2.0 (AIP002)

Applicant Exo Imaging

K-Number K240953

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FYD 2024-08-05

PlumeSafe X5 Smoke Management System

Applicant Conmed Corporation

K-Number K240127

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QVO 2024-08-05

Sleepio®

Applicant Big Health, Inc.

K-Number K233577

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GCJ 2024-08-05

Universal Seal (5-12 mm)

Applicant Intuitive Surgical, Inc.

K-Number K241360

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GEI 2024-08-05

da Vinci E-200 Electrosurgical Generator

Applicant Intuitive Surgical

K-Number K241635

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LLZ 2024-08-05

Orthopaedic Surgery Planning Software (AIJOINT)

Applicant Longwood Valley Medical , Ltd.

K-Number K233761

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QHE 2024-08-05

Precision AI Surgical Planning System (PAI-SPS)

Applicant Precision AI Pty, Ltd.

K-Number K233992

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