Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1483278

FEI Number

1483278

Entity Name

MEDTEC APPLICATIONS, INC.

City/State/Country

Glendale Heights, IL, US

Establishment Address

35 N Brandon Dr, Glendale Heights, IL 60139, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDTEC APPLICATIONS, INC. (Owner Number: 1483278)

Owner / Operator Contact Address

35 N Brandon Drive, --, Glendale Heights, IL 60139, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K960347

PMA Number

N/A

All Registered Proprietary Names

ARTHROSCOPE GYNECOLOGIC (AND ACCESSORIES) LAPAROSCOPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2006-07-25
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	1992-07-27

Official Correspondent

WERNER HAUSNER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDTEC APPLICATIONS, INC.

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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K936071	Smith & Nephew Dyonics, Inc.	SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE	1994-08-19
K953574	American Hydro-Surgical Instruments, Inc.	NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER	1995-09-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

Similar Registrations

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3014615697	AMNOTEC INTERNATIONAL MEDICAL GMBH	Neuhausen ob Eck Baden-Wurttemberg, DE
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1483278. Last updated year: 2026. Please use registration number 1483278 when referencing this establishment in official correspondence.