Phillips-Medisize Costa Mesa LLC

FDA Device Registration & Listing · Costa Mesa, CA, US · Registration 2031044

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2031044
FEI Number
3001236763
Entity Name
Phillips-Medisize Costa Mesa LLC
City/State/Country
Costa Mesa, CA, US
Establishment Address
3545 Harbor Blvd Ste 150, Costa Mesa, CA 92626, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Molex, LLC (Phillips Medsize) (Owner Number: 10023185)
Owner / Operator Contact Address
2202 Carmichael Rd, Hudson, WI 54016, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-09-07
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2016-02-01
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2013-12-23
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-12-23
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2013-12-23
DSQ Ventricular (Assist) Bypass Unknown Class 3 N/A 2013-01-31
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2021-01-14
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2018-03-09
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2013-01-07
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2021-01-14
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2017-05-04
MVK Wearable Automated External Defibrillator Unknown Class 3 N/A 2021-08-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Molex, LLC (Phillips Medsize)
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K881966 C.R. Bard, Inc. ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER 1988-10-04
K192037 ABBOTT MEDICAL Advisor VL Circular Mapping Catheter, Sensor Enabled 2019-09-17
K880323 Medtronic Vascular MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR 1988-03-22
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031044. Last updated year: 2026. Please use registration number 2031044 when referencing this establishment in official correspondence.
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