FDA Registration
Active
🇺🇸 United States
INFINIUM MEDICAL, INC.
Reg #: 1066427
·
FEI: 3007513035
·
Expires 2026
Products
20
Proprietary Names
23
Establishment Types
2
Classifications
20
Registration Details
- Registration Name
- INFINIUM MEDICAL, INC.
- Registration Number
- 1066427
- FEI Number
- 3007513035
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 12151 62ND ST., N,, UNIT 5
- City
- Largo
- State
- FL
- ZIP
- 33773
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103268
Owner / Operator
- Firm Name
- INFINIUM MEDICAL, INC.
- Operator Number
- 10028895
- Address
- 12151 62ND ST N, UNIT 5
- City
- Largo
- State
- FL
- Postal Code
- 33773
- Country
- US
- Correspondent
- Oz Ozkaya
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2010-12-09 |
| Table, Examination, Medical, Powered | LGX | Class 1 | General, Plastic Surgery | No | 2024-07-16 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2017-01-19 |
| Device, Vein Location, Liquid Crystal | KZA | Class 1 | General Hospital | No | 2019-03-14 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2012-07-31 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2012-07-31 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2012-07-31 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2012-07-31 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2012-07-31 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2024-07-16 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2022-04-06 |
| Absorber, Carbon-Dioxide | BSF | Class 1 | Anesthesiology | No | 2023-09-01 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2011-05-17 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-01-06 |
| Gas-Machine, Anesthesia | BSZ | Class 2 | Anesthesiology | No | 2023-09-01 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2025-03-05 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-03-05 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-03-05 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2012-09-18 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2024-07-16 |
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
OMNIVIEW Hospital MDDS
ST300 Operating Room Table
ST500 Operating Room Table
ADS II
VioScan Bladder Scanner
QRS12
OBA-1
CLEO
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device