MADE, UNIVERSITY OF IOWA

FDA Device Registration & Listing · Iowa City, IA, US · Registration 3012701990

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
3012701990
FEI Number
3012701990
Entity Name
MADE, UNIVERSITY OF IOWA
City/State/Country
Iowa City, IA, US
Establishment Address
25 S. Grand Ave, ML 2192, Iowa City, IA 52242, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Made, University of Iowa (Owner Number: 10057549)
Owner / Operator Contact Address
25 S. Grand Ave., ML 2192, Iowa City, IA 52242, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SurgiWings Sales Syringe Adapter Abrons Oral Airway Sindt Ophthalmic Spatula

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-08-14
IQG Adaptor, Holder, Syringe Physical Medicine Class 1 890.5050 2025-08-27
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2018-04-23
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2018-05-31

Official Correspondent

Jeff Kueter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Made, University of Iowa
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
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2014 King Systems Corp. 1
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012701990. Last updated year: 2026. Please use registration number 3012701990 when referencing this establishment in official correspondence.
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