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

MUJ 2024-10-23

Vitesse (5.0)

Applicant Varian Medical Systems

K-Number K241876

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MAX 2024-10-23

BluEX Lumbar Expandable Cage System

Applicant L&K BIOMED Co., Ltd.

K-Number K242829

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MAX 2024-10-23

Scarlet® AL-T

Applicant Spineart SA

K-Number K242589

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NKB 2024-10-23

CD Horizon Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K243007

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HRS 2024-10-23

OIC Small / Mini Fragment Plate System

Applicant The Orthopaedic Implant Company

K-Number K242995

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SAN 2024-10-23

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system

Applicant Affinity Biosensors, LLC

K-Number K241324

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EOQ 2024-10-23

Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)

Applicant Scivita Medical Technology Co., Ltd.

K-Number K240289

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CDZ 2024-10-23

IDS-iSYS Free Testosterone

Applicant Immunodiagnostic Systems Limited

K-Number K240865

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KDN 2024-10-23

KIDNEYvault Portable Renal Perfusion System

Applicant Paragonix Technologies

K-Number K234060

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LLZ 2024-10-23

MIM Symphony HDR Fusion

Applicant Mim Software, Inc.

K-Number K243012

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ONB 2024-10-23

ProSeal Closed System Bag Access

Applicant Epic Medical Pte. , Ltd.

K-Number K241988

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QYM 2024-10-23

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)

Applicant Tsk Laboratory International Japan KK

K-Number K242073

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