HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar...

510(k) Number: BK251199 Applicant: EUROMI S.A Device Name: NLF system® kit 2 (EUROMI)Decision Date: 8/14/2025Supporting Documents Content current as of: 08/15/2025...

[8-13-2025] FDA continues to advise consumers not to purchase or use the Green Lumber Natural Fuel For Men product. FDA laboratory analysis confirmed that additional versions of the Green Lumber product sold by Green Lumber Holdings LLC contain tadalafil. [9-19-2019]...

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes...

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar...