EMBEDTEK, LLC

FDA Device Registration & Listing · Waukesha, WI, US · Registration 3012060713

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
3012060713
FEI Number
3012060713
Entity Name
EMBEDTEK, LLC
City/State/Country
Waukesha, WI, US
Establishment Address
N7W23700 Bluemound Rd Ste 100, Waukesha, WI 53188, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
EmbedTek (Owner Number: 10095357)
Owner / Operator Contact Address
N7W23700 Bluemound Road Suite 100, Waukesha, WI 53188, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2026-03-03
FWJ Camera, Cine, Microsurgical, Without Audio General, Plastic Surgery Class 1 878.4160 2026-03-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EmbedTek
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-2412-2024 Alcon Research LLC Aspex Facility 1
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012060713. Last updated year: 2026. Please use registration number 3012060713 when referencing this establishment in official correspondence.
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