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

OWN 2024-08-19

Histolog® Scanner (Hardware 2.4, Software 3.3)

Applicant Samantree Medical SA

K-Number K241275

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OMP 2024-08-19

Negative Pressure Wound Therapy Device (V-Move, V-Grand)

Applicant Med Way, Inc.

K-Number K241023

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DZI 2024-08-19

MT-Bone

Applicant Mectron S.P.A.

K-Number K242432

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OUR 2024-08-19

iFuse TORQ TNT Implant System

Applicant SI-BONE, Inc.

K-Number K241504

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HRS 2024-08-19

RibFix Titan Fixation System

Applicant Riverpoint Medical

K-Number K241282

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JSM 2024-08-19

OmniTrans Transport System

Applicant Shenzhen Dakewe Bio-Engineering Co., Ltd.

K-Number K240235

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SBF 2024-08-19

OnPoint Augmented Reality Spine System

Applicant Onpoint Surgical, Inc.

K-Number K241870

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JAK 2024-08-19

HealthCCSng

Applicant Nano-X AI , Ltd.

K-Number K241440

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IPF 2024-08-17

BTL-899MS

Applicant BTL Industries, Inc.

K-Number K240234

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NQQ 2024-08-16

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))

Applicant Gentuity, LLC

K-Number K242239

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NTK 2024-08-16

iTero Lumina Pro

Applicant Align Technology , Ltd.

K-Number K240573

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DZE 2024-08-16

JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus

Applicant Jdentalcare Srl

K-Number K233896

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