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

NJR 2023-09-27

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems

Applicant Cepheid

K-Number K222638

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JZO 2023-09-26

Access Thyroglobulin Antibody II

Applicant Beckman Coulter, Inc.

K-Number K213517

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PKT 2023-09-26

DEKA PHYSIQ 360

Applicant El.En S.P.A.

K-Number K231971

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LLZ 2023-09-26

OFIX MIS App

Applicant Orthofix US, LLC

K-Number K230252

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DQK 2023-09-26

AVVIGO'+ Multi-Modality Guidance System

Applicant Boston Scientific Corporation

K-Number K230884

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KWS 2023-09-26

Arthrex Univers Apex OptiFit Humeral Stem

Applicant Arthrex, Inc.

K-Number K230513

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NXC 2023-09-26

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks

Applicant Align Technology, Inc.

K-Number K232233

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IYN 2023-09-26

ES Series V2

Applicant E-Scopics

K-Number K232336

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QVQ 2023-09-26

VasQ

Applicant Laminate Medical Technologies , Ltd.

K-Number DEN220026

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JEY 2023-09-26

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System

Applicant Medcad

K-Number K230398

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CEM 2023-09-26

EasyStat 300

Applicant Medica Corporation

K-Number K220396

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NHA 2023-09-26

Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems

Applicant Prismatik Dentalcraft, Inc.

K-Number K223496

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