Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010086866

FEI Number

3010086866

Entity Name

ONANON, INC

City/State/Country

Milpitas, CA, US

Establishment Address

720 South Milpitas Blvd, Milpitas, CA 95035, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Onanon, Inc (Owner Number: 10062448)

Owner / Operator Contact Address

720 South Milpitas Blvd, Milpitas, CA 95035, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Percutaneous Catheter Ultrasound Percutaneous Catheter Ultrasound Shockwave Intravascular Lithotripsy System Percutaneous Catheter Ultrasound Percutaneous Catheter Ultrasound

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2021-03-04
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2021-03-04
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Unknown	Class 3	N/A	2022-06-01
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Unknown	Class 3	N/A	2022-06-01
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Unknown	Class 3	N/A	2022-06-01
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2022-06-01
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2022-06-01
QMG	Shockwave Intravascular Lithotripsy System	Unknown	Class 3	N/A	2021-03-04
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2020-01-28
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2021-03-04

Official Correspondent

Dennis Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Onanon, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2018	St. Jude Medical, Inc.	3	Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
Z-0459-2026	Abbott Medical	3	Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Z-2265-2024	Abbott Medical	3	Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664

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2030598	Synergy Health AST, LLC	SAN DIEGO, CA, US
2030624	Isomedix Operations, Inc.	Temecula, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010086866. Last updated year: 2026. Please use registration number 3010086866 when referencing this establishment in official correspondence.