INVENTEX MEDICAL

FDA Device Registration & Listing · Niles, IL, US · Registration 3009495876

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
3009495876
FEI Number
3009495876
Entity Name
INVENTEX MEDICAL
City/State/Country
Niles, IL, US
Establishment Address
7415 N Melvina Ave, Niles, IL 60714, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Inventex Medical (Owner Number: 10040210)
Owner / Operator Contact Address
7415 N. Melvina Av., Niles, IL 60714, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ZQuiet

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2021-01-11
NWT Endoscopic Cholangiogram Kit Gastroenterology, Urology Class 2 876.1500 2019-08-13
LRK Device, Anti-Snoring Dental Class 2 872.5570 2021-05-18
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2018-05-29
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-04-07
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2020-02-27
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-03-06
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2020-12-17
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 2021-01-21
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2013-01-24
JEP Retainer, Matrix Dental Class 1 872.4565 2020-02-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-08-23
ODR Electrosurgical Patient Return Electrode General, Plastic Surgery Class 2 878.4400 2013-08-23
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2022-12-29
GBZ Catheter, Cholangiography General, Plastic Surgery Class 1 878.4200 2014-07-15
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2012-03-19

Official Correspondent

Steven Amundson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Inventex Medical
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
K122391 Medtronic Xomed, Inc. MEDTRONIC XOMED, INC. 2013-01-10
K945777 Smiths Industries Medical Systems, Inc. PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES 1994-12-22
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09
K831136 Almore Intl., Inc. DOUBLE BOW TOOTH SEPARATOR 1983-06-08
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2014 Perkin Elmer Health Sciences, Inc. 2
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
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
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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3001614464 medi-G GMBH Messkirch Baden-Wurttemberg, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009495876. Last updated year: 2026. Please use registration number 3009495876 when referencing this establishment in official correspondence.
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