FDA Registration
Active
🇺🇸 United States
Phillips-Medisize Costa Mesa LLC
Reg #: 2031044
·
FEI: 3001236763
·
Expires 2026
Products
10
Proprietary Names
12
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Phillips-Medisize Costa Mesa LLC
- Registration Number
- 2031044
- FEI Number
- 3001236763
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3545 Harbor Blvd Ste 150
- City
- Costa Mesa
- State
- CA
- ZIP
- 92626
- Country
- US
Owner / Operator
- Firm Name
- Molex, LLC (Phillips Medsize)
- Operator Number
- 10023185
- Address
- 2202 Carmichael Rd
- City
- Hudson
- State
- WI
- Postal Code
- 54016
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2023-09-07 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2016-02-01 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2013-12-23 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2013-12-23 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2013-12-23 |
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2013-01-31 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2021-01-14 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2017-05-04 |
| Wearable Automated External Defibrillator | MVK | Class 3 | Unknown | No | 2021-08-19 |
| Eyelid Thermal Pulsation System | ORZ | Class 2 | Ophthalmic | No | 2022-02-22 |
Proprietary Names
POLARMAPTM EP Electrical Cable
Cable, Easy-Mate
Cable, 3 LD AAMI ECG to MS
HeartWare Ventricular Asist System
SureLink Extension Cable
SureLink Extension Cables
Carto 3 Cables
ASSURE® Wearable Cardioverter Defibrillator (WCD) system
Carto 3 System Interface Cable
Interface Cable
TearCare System SmartHub Kit
Carto 3 System ECO Interface Cable
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)