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

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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QXQ 2024-08-12

SoClean 3+ Bacterial Reduction Device

Applicant Soclean, Inc.

K-Number DEN210037

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PQM 2024-08-12

Ultravision2 IonPencil

Applicant Alesi Surgical Limited

K-Number K240868

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GEX 2024-08-12

Eneka Selectif

Applicant Termosalud

K-Number K241656

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NUH 2024-08-12

Pixie Pulse (SM9068)

Applicant Pixie Cup, LLC

K-Number K241365

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QIH 2024-08-12

OptimMRI (v2)

Applicant Rebrain, Sas

K-Number K242054

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CHH 2024-08-09

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES

Applicant Medicon Hellas S.A

K-Number K232404

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DQK 2024-08-09

EnSite X EP System

Applicant ABBOTT MEDICAL

K-Number K242016

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