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

NHA 2025-12-09

Atlantis® Abutments in Titanium

Applicant Dentsply Sirona

K-Number K252343

View Details →

QKQ 2025-12-09

INFINITT DPS

Applicant Infinitt Healthcare Co., Ltd.

K-Number K243449

View Details →

OWB 2025-12-09

Allia Moveo

Applicant GE Medical Systems SCS

K-Number K251199

View Details →

GEH 2025-12-09

Focused Cryotherapy System

Applicant Focused Cryo, Inc.

K-Number K250742

View Details →

NGX 2025-12-09

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)

Applicant Guangzhou Longest Medical Technology Co., Ltd.

K-Number K252154

View Details →

JOW 2025-12-08

Sequential Compression System (SCD600)

Applicant Shenzhen Comen Medical Instruments Co.,Ltd

K-Number K250190

View Details →

ITI 2025-12-08

Electric Wheelchair (DH01126)

Applicant Foshan Dahao Medical Technology Co., Ltd.

K-Number K252862

View Details →

OHS 2025-12-08

LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)

Applicant Guangdong Ace-Tec Co., Ltd.

K-Number K252994

View Details →

POK 2025-12-08

Fetal EchoScan (v1.2)

Applicant Brightheart

K-Number K252294

View Details →

NCG 2025-12-08

Ceribell Delirium Monitor System

Applicant Ceribell, Inc.

K-Number K251936

View Details →

EIH 2025-12-08

Glass Ceramic

Applicant Shenzhen Xiangtong Co., Ltd.

K-Number K252789

View Details →

DXH 2025-12-08

HeartBeam AIMIGo with 12-L ECG Synthesis Software System

Applicant Heartbeam, Inc.

K-Number K250258

View Details →

Page 121 of 2685

↑