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

FMK 2024-08-15

Medifun Safety Lancet ( MSL1 series)

Applicant Medifun Corporation

K-Number K241750

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KNS 2024-08-15

Reusable Interface Cable 1.5 m (PRD-IFC-002)

Applicant Creo Medical, Ltd.

K-Number K242061

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QIH 2024-08-15

CoLumbo

Applicant Smart Soft Healthcare

K-Number K241211

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DZE 2024-08-15

TOV Dental Implant System

Applicant Rdj Tov Implant, Ltd.

K-Number K240837

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GCJ 2024-08-15

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

Applicant Stryker Endoscopy

K-Number K241401

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KPS 2024-08-15

uMI Panvivo

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K241596

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FMF 2024-08-15

Disposable Pen Injector Assembly

Applicant Wuxi Nest Biotechnology Co., Ltd.

K-Number K240961

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LOX 2024-08-15

Sapphire ULTRA Coronary Dilatation Catheter

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K-Number K233505

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HRS 2024-08-15

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate

Applicant Zimmer Switzerland Manufacturing GmbH

K-Number K241754

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OKO 2024-08-15

NPseal (20 and 25)

Applicant Guard Medical, Inc.

K-Number K241522

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HQD 2024-08-14

BostonSight® Specialty Lenses

Applicant Boston Foundation For Sight, Inc. D/B/A Bostonsight

K-Number K241571

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NFT 2024-08-14

PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup

Applicant Aicheck Biotech, Inc.

K-Number K242077

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