Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1066427

FEI Number

3007513035

Entity Name

INFINIUM MEDICAL, INC.

City/State/Country

Largo, FL, US

Establishment Address

12151 62ND ST., N,, UNIT 5, Largo, FL 33773, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

INFINIUM MEDICAL, INC. (Owner Number: 10028895)

Owner / Operator Contact Address

12151 62ND ST N, UNIT 5, Largo, FL 33773, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241161

PMA Number

N/A

All Registered Proprietary Names

Omni Express Omni VS Le Mans Exam Table ClearVue, ClearVue XL Video Laryngoscopes VS 30, VS 400, VS 500 Vein Finders Omni, Omni K Luxor 100, 200, 300, 400 Surgical Lights ThermH2OSorb ATS Omni III Omni II Omni II K Edge 80, 160, 200, 400 Electrosurgical Units OBA-1 MRI VioScan L2, C7 Portable Ultrasound

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2010-12-09
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2024-07-16
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2017-01-19
KZA	Device, Vein Location, Liquid Crystal	General Hospital	Class 1	880.6970	2019-03-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-07-31
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2012-07-31
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2012-07-31
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2012-07-31
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2012-07-31
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2012-07-31
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2024-07-16
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2022-04-06
BSF	Absorber, Carbon-Dioxide	Anesthesiology	Class 1	868.5310	2023-09-01
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2011-05-17
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2010-09-13
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2011-06-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-01-06
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2023-09-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-03-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-03-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-03-05

Official Correspondent

Oz Ozkaya

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INFINIUM MEDICAL, 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
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09
K124061	Invivo Corporation	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	2013-02-22
K101264	Remote Diagnostic Technologies , Ltd.	TEMPUS IC PROFESSIONAL PATIENT MONITOR	2010-05-11
K113105	Remote Diagnostic Technologies , Ltd.	TEMPUSIC PATIENT MONITOR	2011-12-15
K134014	Remote Diagnostic Technologies , Ltd.	TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)	2014-08-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Z-0042-2015	Mckesson Information Solutions LLC	2	McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Z-2183-2011	Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom	2	TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1066427. Last updated year: 2026. Please use registration number 1066427 when referencing this establishment in official correspondence.