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 2022-04-29

FreedomEdge Syringe Infusion System

Applicant Repro-Medical System, Inc., Dba Koru Medical Systems

K-Number K214045

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GEX 2022-04-29

LISA Laser Surgical Fibers

Applicant Omni-Guide Holdings, Inc.

K-Number K220189

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MUA 2022-04-29

Bindex BI-2

Applicant Bone Index Finland , Ltd.

K-Number K211350

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FGB 2022-04-29

Monarch Platform, Urology

Applicant Auris Health, Inc.

K-Number K213334

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KRD 2022-04-29

LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)

Applicant Okami Medical

K-Number K220383

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QSN 2022-04-29

BioFire Joint Infection (JI) Panel

Applicant Biofire Diagnostics, LLC

K-Number DEN200066

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EZD 2022-04-29

BONREE Nelaton Catheter

Applicant Bonree Medical Co., Ltd.

K-Number K212430

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NTK 2022-04-29

TIA Tip, Cariosity, Transillumination Accessory Tip

Applicant D4D Technologies, LLC

K-Number K213482

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GDW 2022-04-29

GIA Stapler with Tri-Staple Technology

Applicant Covidien

K-Number K221006

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KPR 2022-04-29

Hand Diagnostic Radiography Imaging System

Applicant Nanoray Biotech Co., Ltd.

K-Number K220271

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QEP 2022-04-29

Alinity m STI Assay

Applicant Abbott Molecular, Inc.

K-Number K202977

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KCT 2022-04-29

SteriTite Container System with MediTray Products

Applicant Case Medical, Inc.

K-Number K212711

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