Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043769

FEI Number

1000179044

Entity Name

ITM Industria de Tecnologias Medicas LTDA

City/State/Country

CANOAS Rio Grande do Sul, BR

Establishment Address

RUA BERTO CIRIO, 751, CANOAS Rio Grande do Sul 92420-030, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ITM Industria de Tecnologias Medicas LTDA (Owner Number: 9003722)

Owner / Operator Contact Address

Rua Berto Cirio, 751, Canoas, BR-RS 92420-030, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Retractor Nasal Scissors ENT Elevator Self Retaining Retractor Cardiovascular Surgical Instruments Wire Cutting Scissors OB-GYN Manual Instrument ENT Manual Surgical Instrument Needle Holder Ophthalmic Retractor Aspiration and Injection Needle Metal Vaginal Speculum Surgical Clamp Surgical Tray Orthopedic Surgical Scissors Forceps Tongue Depressor Microsurgical Instrument G-U Surgical Instruments Extractor Trocar Surgical Pliers GEN Forceps Compression Instrument Cannula HGT Hemostatic Clip Applier Retractor Orthopedic Needle Holder Surgical Rongeur Forceps Rongeur Non-Self Retaining Retractor Suction Operatory Unit Surgical Dissector Umbilical Scissors Disposable Scissors Manual - General Surgical Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1992-06-25
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2009-04-17
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	1994-03-29
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1992-06-25
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1992-06-25
JYA	Scissors, Wire Cutting, Ent, Sterile	Ear, Nose, Throat	Class 1	874.3540	1992-06-25
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2003-08-19
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2003-08-19
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1996-04-15
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	1992-06-25
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-04-17
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2009-04-17
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2003-11-03
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2003-08-19
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2009-04-17
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1996-04-15
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	1992-06-25
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2003-08-19
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2003-08-19
HWB	Extractor	Orthopedic	Class 1	888.4540	1996-04-15
FBQ	Trocar, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5090	2009-04-17
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-11-03
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-02-18
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2009-04-17
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-04-17
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	1995-04-11
EIG	Retractor, All Types	Dental	Class 1	872.4565	1996-04-15
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2009-04-17
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1992-06-25
HTX	Rongeur	Orthopedic	Class 1	888.4540	2009-04-17
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1992-06-25
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	1992-06-25
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2003-08-19
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2009-04-17
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1992-06-25
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2003-08-19

Official Correspondent

Mario Frizzo

US Agent Details

Joseph Azary Business: Aztech Regulatory and Quality LLC Email: aztechregulatory@gmail.com Phone: (203) 2426670

Related Public Records

Same Entity

ITM Industria de Tecnologias Medicas LTDA

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

Similar Registrations

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3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043769. Last updated year: 2026. Please use registration number 8043769 when referencing this establishment in official correspondence.