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

OUR 2024-08-13

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

Applicant Si-Technology, LLC

K-Number K241813

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LNH 2024-08-13

ECHELON Synergy MRI System

Applicant Fujifilm Healthcare Corporation

K-Number K241429

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HRS 2024-08-13

CoLink NeoFuse MIS Plating System (see attached parts list)

Applicant In2bones USA

K-Number K241387

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GEX 2024-08-13

SUPER VELOCE

Applicant Ilooda Co,., Ltd.

K-Number K241699

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CBK 2024-08-13

VM-2000

Applicant Ventis Medical, Inc.

K-Number K240807

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GEX 2024-08-13

Diode Laser Therapy Device (DF-DIODE LASER-S1)

Applicant Weifang Dragonfly Electronics Technology Co., Ltd.

K-Number K241547

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OVE 2024-08-12

E3D™-C Interbody System

Applicant Evolution Spine

K-Number K241846

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MAX 2024-08-12

aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)

Applicant Carlsmed, Inc.

K-Number K241328

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GCJ 2024-08-12

Medical Monitor (32HR734S)

Applicant Lg Electronics.Inc

K-Number K241402

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LSR 2024-08-12

iDart Lyme IgG ImmunoBlot Kit

Applicant Id-Fish Technology, Inc.

K-Number K233367

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MOS 2024-08-12

dS FootAnkle Coil 8ch 1.5T

Applicant Philips Medical Systems Nederland B.V.

K-Number K242096

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PQM 2024-08-12

Ultravision2™ IonPencil

Applicant Alesi Surgical Limited

K-Number K240868

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