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

EBF 2024-04-25

Temporis, Irix Plus

Applicant Dws S.R.L.

K-Number K231142

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EFB 2024-04-25

Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)

Applicant Nakanishi, Inc.

K-Number K233308

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HRX 2024-04-25

Digital ClarusScope System; Digital NeuroPEN System

Applicant Clarus Medical, LLC

K-Number K240535

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OAS 2024-04-25

Dental Cone-beam Computed Tomography

Applicant Yian Medical Technology (Haining) Co., Ltd.

K-Number K240855

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LZO 2024-04-24

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K234025

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MQL 2024-04-24

SSS-NX (Serum Substitute Supplement-NX)

Applicant Fujifilm Irvine Scientific

K-Number K233764

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SBF 2024-04-24

NextAR™ Spine Platform

Applicant Medacta International S.A.

K-Number K233172

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OVD 2024-04-24

Omnia Medical TiBrid™-SA System

Applicant Omnia Medical, LLC

K-Number K240623

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LLZ 2024-04-24

Image Management V15

Applicant Philips Medical Systems Technologies

K-Number K240822

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NHA 2024-04-24

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K240208

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OHT 2024-04-24

IPL Home Use Hair Removal Device (SJ15)

Applicant Shenzhen Shuge Medical Beauty Devices Co., Ltd.

K-Number K240093

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IYN 2024-04-24

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

Applicant Philips Ultrasound, LLC

K-Number K240850

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