5 premarket notifications (510(k)s) from applicants based in Puerto Rico were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.
| Decided | Applicant | Device | Area | Where | Record |
|---|---|---|---|---|---|
| 2026-09-17 | Ethicon Endo-Surgery, LLC | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) GEI | General, Plastic Surgery | Guaynabo, Puerto Rico | K254196 |
| 2026-06-15 | JJGC Indústria e Comércio de Materiais Dentários S.A. | Neodent Scannable Healing Abutment NHA | Dental | Curitiba, Puerto Rico | K253922 |
| 2026-05-11 | Ethicon Endo-Surgery, LLC | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm) GDW | General, Plastic Surgery | Guaynabo, Puerto Rico | K260196 |
| 2026-01-09 | Ethicon Endo-Surgery, LLC | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) OXC | General, Plastic Surgery | Guaynabo, Puerto Rico | K252906 |
| 2025-12-17 | Ethicon Endo-Surgery, LLC | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) GDW | General, Plastic Surgery | Guaynabo, Puerto Rico | K252739 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
Cite this page
https://mentionfox.com/fda/510k/state/pr