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

GXN 2026-01-14

METICULY Patient-specific titanium mesh implant

Applicant Meticuly Co., Ltd.

K-Number K252958

View Details →

IYE 2026-01-14

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface

Applicant Brainlab SE

K-Number K254010

View Details →

GEI 2026-01-14

ENTire IRE System

Applicant Entire Medical , Ltd.

K-Number K251996

View Details →

QJI 2026-01-14

SmartGuard technology; Predictive Low Glucose technology

Applicant Medtronic Minimed, Inc.

K-Number K253585

View Details →

BTT 2026-01-14

Laboratorios Biogalenic Sterile Water for Inhalation, USP

Applicant Laboratorios Biogalenic S.A. DE C.V.

K-Number K251419

View Details →

ODP 2026-01-14

Cervical Interbody and VBR Fusion System

Applicant Sync Surgical

K-Number K252219

View Details →

LZC 2026-01-14

Cardinal Health Nitrile Examination Gloves Extended Cuff

Applicant Cardinalhealth

K-Number K252313

View Details →

OXO 2026-01-14

Orthoscan TAU MVP Mini C-Arm System

Applicant Ziehm-Orthoscan, Inc.

K-Number K252579

View Details →

MOS 2026-01-14

dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T

Applicant Philips Medical Systems Nederland B.V.

K-Number K254190

View Details →

KRD 2026-01-14

Concerto Versa™ Detachable Coil

Applicant Medtronic, Inc.

K-Number K253511

View Details →

QNI 2026-01-13

BEAR® (Bridge-Enhanced ACL Restoration) Implant

Applicant Miach Orthopaedics, Inc.

K-Number K251214

View Details →

GCJ 2026-01-13

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

Applicant Stryker Endoscopy

K-Number K254014

View Details →

Page 165 of 2728

↑