FDA Registration
Active
🇺🇸 United States
PLEXUS CORP.
Reg #: 3004105270
·
FEI: 3004105270
·
Expires 2026
Products
18
Proprietary Names
24
Establishment Types
1
Classifications
18
Registration Details
- Registration Name
- PLEXUS CORP.
- Registration Number
- 3004105270
- FEI Number
- 3004105270
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2400 Millbrook Dr
- City
- BUFFALO GROVE
- State
- IL
- ZIP
- 60089
- Country
- US
Owner / Operator
- Firm Name
- PLEXUS CORP.
- Operator Number
- 3019588
- Address
- ONE PLEXUS WAY, --
- City
- Neenah
- State
- WI
- Postal Code
- 54956
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2018-07-31 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2015-08-19 |
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2022-02-25 |
| Cerebral Oximeter | QEM | Class 2 | Cardiovascular | No | 2022-02-25 |
| Modular Electromechanical Surgical System | SCV | Class 2 | General, Plastic Surgery | No | 2026-01-02 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2018-05-23 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2015-08-18 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2025-06-30 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2025-06-30 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2025-06-30 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2017-11-29 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2019-12-06 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2013-01-25 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2025-04-24 |
| System/Device, Pharmacy Compounding | NEP | Class 2 | General Hospital | No | 2017-11-21 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2013-01-25 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2013-09-09 |
| Permanent Defibrillator Electrodes | NVY | Class 3 | Unknown | No | 2013-09-09 |
Proprietary Names
Dexcom G6 Continuous Glucose Monitoring System
Revolve System
PMPAMP71 INVOS Preamplifier
Legacy EX/ST system
Hugo Robotically Assisted Surgery (RAS) System
Genmark EPLEX
Urology
RFG3 Generator
HexaFlow Irrigation Pump - AFR-00005
Sphere S9 Catheter Extension Cable
HexaGen RF Generator - AFR-00004
HexaPulse PF Generator - AFR-00008
Latitude 3300
Stealth Autoguide System
Pre-Amp PMPAMP71
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System (Control module and Holster)
Cryocath system
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System (Holster)
Affera Integrated Mapping System
Exactamix
Barrx Flex RFA Energy Generator
AV6060 Impulse controller
EMBLEM S-ICD Programmer
Legacy MR system
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)