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

MOF 2026-03-16

DCwire Micro-guidewire

Applicant Shanghai Achieva Medical Suzhou Co., Ltd.

K-Number K252122

View Details →

PGW 2026-03-16

Stealth AXiS ENT clinical application

Applicant Medtronic Navigation, Inc.

K-Number K253395

View Details →

NRY 2026-03-16

Millipede System

Applicant Perfuze, Ltd.

K-Number K253590

View Details →

DZE 2026-03-16

ZENEX Implant System_Short (R-System)

Applicant Izenimplant Co., Ltd.

K-Number K253334

View Details →

DJC 2026-03-16

Healgen® Accurate Oral Fluid Drug Test

Applicant Healgen Scientific,, LLC

K-Number K253705

View Details →

NKG 2026-03-16

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System

Applicant CarboFix Orthopedics , Ltd.

K-Number K254045

View Details →

IYN 2026-03-16

Sonio Detect (v3)

Applicant Sonio

K-Number K252433

View Details →

OHS 2026-03-16

Ulike Reglow Light Therapy Device (UM10)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K260511

View Details →

GXR 2026-03-16

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)

Applicant Orthocon, Inc.

K-Number K253447

View Details →

HRS 2026-03-16

APTUS Shoulder Proximal Humerus System, PentaLock 3.5

Applicant Medartis AG

K-Number K253916

View Details →

OHS 2026-03-16

LED Light Therapy Mask (Models: T2, RLD10)

Applicant Shenzhen Desida Technology Co., Ltd.

K-Number K254079

View Details →

IKT 2026-03-15

Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)

Applicant Technomed Europe

K-Number K253581

View Details →

Page 52 of 2685

↑