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

OWY 2025-06-04

Tendon Protect (50242)

Applicant Kerecis Limited

K-Number K243843

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OLO 2025-06-04

Paradigm System

Applicant Proprio, Inc.

K-Number K250879

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DRA 2025-06-03

Globe Introducer (601-01001)

Applicant Kardium, Inc.

K-Number K250529

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JOJ 2025-06-03

DISINTEK™ PA Test Strips

Applicant Serim Research

K-Number K251035

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JXG 2025-06-03

EVAC

Applicant Phasor Health, LLC

K-Number K243205

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PEA 2025-06-03

PENTAX Medical Video Processor (EPK-i8020c)

Applicant Pentax of America, Inc.

K-Number K251127

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NRY 2025-06-03

Raptor Aspiration Catheter; Balt Aspiration Tubing Set

Applicant Balt USA, LLC

K-Number K243948

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EBI 2025-06-03

Partial Flex

Applicant Clemde SA DE CV

K-Number K242897

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GEI 2025-06-03

gi2000 Electrosurgical Generator

Applicant Cintron Medical Corporation

K-Number K250657

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FTM 2025-06-03

Endoform Reconstructive Template - PLGA

Applicant Aroa Biosurgery , Ltd.

K-Number K250598

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FOZ 2025-06-03

BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K250682

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LZA 2025-06-03

GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

Applicant Glove One, LLC

K-Number K243796

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