Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012263546

FEI Number

3012263546

Entity Name

ATL Technology CR Limitada

City/State/Country

Alajuela, CR

Establishment Address

Flexipark Industrial Park, Buildings G1, G2, G3, G4, G5, E3, E4, F5, F6, F7 & F8, Alajuela 20108, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ATL Technology LLC (Owner Number: 10058346)

Owner / Operator Contact Address

1335 West 1650 North, Springville, UT 84663, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Irrigation Poly Tube Assembly RIO System Irrigation Silicone Tubing, Non Sterile MAKO CIQ Controller NVM5 MEP/EMG Harness NVM5 EMG Harness NVM5 SSEP Harness CIQ SpineWand Perc-D SpineWand Flyte Power Cord ThermaClear Scope Outflow Tube Set FluidSmart Inflow Tube Set FluidSmart Urology Tube Set FluidSmart Inflow/Outflow Tube Set ThermaClear Inflow Tube Set Nasal Alar Sp02 Sensor Harmony Ensite X EP System Advisor SE Connection Cable Ensite Precision EnSite X EP System Catheter Connector Cable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-01-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-21
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-09-11
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2018-09-11
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2018-09-11
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2018-09-11
PUK	Administration Set Securement Device	General Hospital	Class 1	880.5210	2020-05-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-03-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-01-04
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-09-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2022-11-02
NVT	Tubing And Tubing/Filter Fits	Obstetrics/Gynecology	Class 1	884.1700	2025-07-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-01-04
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2023-12-21
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2019-07-31

Official Correspondent

No official correspondent registered.

US Agent Details

Lauren Cordova Business: ATL Technology Email: laurenc@atltechnology.com Phone: (801) 8534035

Related Public Records

Same Entity

ATL Technology LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007015148	ATL TECHNOLOGY LLC	Springville, UT, US
3010280625	ATL Technology DG,Ltd.	Dongguan Guangdong, CN
9617070	GYRUS MEDICAL LTD.	CARDIFF Wales, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
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
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012263546. Last updated year: 2026. Please use registration number 3012263546 when referencing this establishment in official correspondence.