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

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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LLZ 2022-04-29

aPROMISE X

Applicant Exini Diagnostics AB

K-Number K220590

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IYE 2022-04-29

ExacTrac Dynamic

Applicant Brainlab AG

K-Number K220338

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LNH 2022-04-29

MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A

Applicant Siemens Medical Solutions USA, Inc.

K-Number K220939

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FRN 2022-04-29

Spectrum IQ Infusion System with Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K-Number K220417

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DHN 2022-04-29

Zeus IFA ANA HEp-2 Test System, Zeus dIFine

Applicant Zeus Scientific, Inc.

K-Number K201956

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GDW 2022-04-29

EEA Circular Stapler with Tri-Staple Technology

Applicant Covidien

K-Number K221005

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