LIKELY ACTIVELAST SEEN IN FEDERAL DATA AUG 2026 · 2 SOURCES
Operating signal within 24 months, or from a single source.
What they make
Surgical and Medical Instrument Manufacturing339112Products
Made or handled here · 23
Aortic Valve, Prosthesis, Percutaneously Delivered · Balloon Aortic Valvuloplasty · Cardiovascular Delivery Catheter System Positioning And Stabilization Device · Catheter, Continuous Flush · Catheter, Embolectomy · Catheter, Septostomy · Clamp, Vascular · Heart-Valve, Non-Allograft Tissue · Holder, Heart-Valve, Prosthesis · Instruments, Surgical, Cardiovascular · Introducer, Catheter · Left Atrial Appendage Clip, Implantable · Mitral Valve Repair Devices · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · Percutaneously Delivered Prostheses And Tricuspid Valves · Prosthesis, Mitral Valve, Percutaneously Delivered · Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter · Pulmonary Valve Prosthesis Percutaneously Delivered · Replacement Heart-Valve · Ring, Annuloplasty · Sizer, Heart-Valve, Prosthesis · Stabilizer, Heart · Tray, Surgical, InstrumentWhere these came from
23 from FDA device registration · Federal registry
FDA device establishment 2015691, product code NPT; proprietary names: Edwards Expandable Introducer Sheath Set, Edwards SAPIEN XT Transcatheter Heart Valve, Qualcrimp crimping acc
Where it is
33.69684, -117.84602 · CENSUS TIGER
Other plants nearby
| Facility | City | Industry | Status | Distance |
|---|---|---|---|---|
| Dinsmore & Associates, LLC | Irvine | Plastics Material and Resin Manufacturing 325211 | ACTIVE | 0.1 KM |
| Del Mar Avionics | Irvine | Surgical and Medical Instrument Manufacturing 339112 | UNVERIFIED | 0.3 KM |
| Continuum Diagnostics LLC | Irvine | Surgical and Medical Instrument Manufacturing 339112 | LIKELY ACTIVE | 0.4 KM |
| Shiley INC | Irvine | Surgical and Medical Instrument Manufacturing 339112 | UNVERIFIED | 0.6 KM |
| Irvine Dental | Irvine | Dental Equipment and Supplies Manufacturing 339114 | LIKELY ACTIVE | 0.6 KM |
Also at this address
No other federal record shares this street address.
WHERE THIS RECORD COMES FROM — 2 FEDERAL SOURCES, 6 FIELDS
Every fact on this page traces to a public federal filing. The table below names which register holds this facility, whether that register proves the plant operates or only that it exists, and when each of them last saw it.
EPA cross-references this facility in RCRAINFO · EPA site type STATIONARY.
| Source | Evidence | First seen | Last seen |
|---|---|---|---|
| FDA DEVICES | OPERATING | AUG 2026 | AUG 2026 |
| EPA FRS | EXISTENCE | MAR 2018 | MAR 2018 |
FIELD BY FIELD — WHICH SOURCE SUPPLIED WHAT
| FIELD | SOURCE | SIGNAL |
|---|---|---|
| ADDRESS LINE1 | EPA FRS | JUL 2026 |
| CITY | EPA FRS | JUL 2026 |
| GEOM | EPA FRS | JUL 2026 |
| NAME | EPA FRS | JUL 2026 |
| RCRA GENERATOR STATUS | EPA ECHO | AUG 2026 |
| STATE | EPA FRS | JUL 2026 |
Status is computed from independent sources; nothing here is self-reported unless marked Claimed.