Hospitec USA

FDA Device Registration & Listing · Fort Smith, AR, US · Registration 3008009298

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
3008009298
FEI Number
3008009298
Entity Name
Hospitec USA
City/State/Country
Fort Smith, AR, US
Establishment Address
3730 Wheeler Ave, Fort Smith, AR 72901, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Hospitec USA (Owner Number: 10030442)
Owner / Operator Contact Address
3730 Wheeler Ave, Fort Smith, AR 72901, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K954500
PMA Number
N/A

All Registered Proprietary Names

Medi Bulter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2009-10-05

Official Correspondent

Ryan Embree

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hospitec USA
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
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

Similar Registrations

Registration Number Establishment Name Location
3027338968 RONCADELLE OPERATIONS SRL Castel Mella Brescia, IT
3000214934 ALMAC PHARMA SERVICES LLC Audubon, PA, US
3006850123 JAPAN IRRADIATION SERVICE CO., LTD Naka-gun Ibaraki, JP
3029328631 PEGASUS IMPORTS Houston, TX, US
3010621964 ATLAS MEDICAL PRODUCTS LLC Hialeah, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008009298. Last updated year: 2026. Please use registration number 3008009298 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.