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

GEI 2025-11-17

TS-RF Generator (STS10)

Applicant Starmed Co., Ltd.

K-Number K251566

View Details →

MYN 2025-11-17

DTX Studio Assist

Applicant Nobel Biocare C/O Medicim NV

K-Number K252086

View Details →

LFX 2025-11-17

Access Rubella IgG

Applicant Beckman Coulter, Inc.

K-Number K250588

View Details →

LZA 2025-11-17

Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Mercator Medical (Thailand), Ltd.

K-Number K251141

View Details →

IYN 2025-11-17

ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K253487

View Details →

FRF 2025-11-14

Biomoneta Avata Rx

Applicant Biomoneta Research Private Limited

K-Number K251872

View Details →

FIP 2025-11-14

AquaC UNO H

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K250471

View Details →

KCT 2025-11-14

Sterilization Trays

Applicant Paragon Implant Mfg., LLC

K-Number K251756

View Details →

OHT 2025-11-14

IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)

Applicant Alovea Healthcare Co. , Ltd.

K-Number K252618

View Details →

SDO 2025-11-14

ARC-EX System

Applicant Onward Medical, Inc.

K-Number K251821

View Details →

HQC 2025-11-14

System Sophi

Applicant This AG

K-Number K250501

View Details →

SCA 2025-11-14

Status COVID-19/Flu A&B

Applicant Princeton BioMeditech Corp.

K-Number K251538

View Details →

Page 136 of 2685

↑