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

MQB 2025-10-09

Lux HD 2530 detector (Lux HD 2530)

Applicant Iray Imaging Technology (Haining) Limited

K-Number K252911

View Details →

NFT 2025-10-09

VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup

Applicant Advin Biotech, Inc.

K-Number K252867

View Details →

OUR 2025-10-09

iFuse Bedrock Granite Implant System

Applicant SI-BONE, Inc.

K-Number K253094

View Details →

NFO 2025-10-09

Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)

Applicant Shenzhen Jianchao Intelligent Technology Co., Ltd.

K-Number K252553

View Details →

NXC 2025-10-09

Invisalign Specifix Attachment System

Applicant Align Technology, Inc.

K-Number K252870

View Details →

HEB 2025-10-09

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

Applicant Cotton High Tech S.L.

K-Number K252939

View Details →

OHS 2025-10-09

ORA Method LED Gua Sha (GS-04)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K252272

View Details →

MRC 2025-10-09

cleadew GP hydra one

Applicant Ophtecs Corporation

K-Number K251876

View Details →

ODC 2025-10-09

Orca Air/Water and Suction Valves

Applicant Boston Scientific

K-Number K252910

View Details →

DXN 2025-10-09

Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)

Applicant Honsun (Nantong) Co., Ltd.

K-Number K251795

View Details →

LFL 2025-10-08

CUSA® Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K-Number K251162

View Details →

DYB 2025-10-08

14Fr Low Profile Introducer Kit

Applicant Abiomed, Inc.

K-Number K252766

View Details →

Page 163 of 2685

↑