Data / Medical devices / United States / Infinium Medical, Inc.
Infinium Medical, Inc.: FDA-registered device maker in Largo, FL, United States, 14 510(k) clearances
Infinium Medical, Inc. is registered with the FDA (registration 1066427) in Largo, FL, United States. It lists 20 device types. The FDA files 14 510(k) clearances under its listings, the newest dated September 11, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1066427
- FEI number
- 3007513035
- Address
- 12151 62ND ST., N, Unit 5, Largo, FL, United States, 33773
- Owner or operator
- INFINIUM MEDICAL, INC. (10028895)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- September 13, 2010
- Registered through
- 2026
- Brand names listed
- ADS II, ATS, CLEO, ClearVue, ClearVue XL Video Laryngoscopes, Edge 80, 160, 200, 400 Electrosurgical Units, Le Mans Exam Table, Luxor 100, 200, 300, 400 Surgical Lights, OBA-1 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2024 | K241161 | Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging | IYN | Substantially Equivalent | Leltek, Inc. | accessdata.fda.gov |
| October 24, 2023 | K232638 | FilteredFlo Warming Blankets | DWJ | Substantially Equivalent | Iob Medical, Inc. | accessdata.fda.gov |
| June 30, 2023 | K231596 | IOB Temperature Management System | DWJ | Substantially Equivalent | Iob Medical, Inc. | accessdata.fda.gov |
| October 5, 2022 | K220138 | Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP | GEI | Substantially Equivalent | Led Spa | accessdata.fda.gov |
| June 5, 2019 | K191307 | Palm Bladder Scanner - PBSV5.1 | IYO | Substantially Equivalent | Mianyang Meike Electronic Equipment Co., Ltd. | accessdata.fda.gov |
| February 6, 2015 | K142244 | CLEO PATIENT MONITOR | MWI | Substantially Equivalent | Infinium Medical | accessdata.fda.gov |
| May 9, 2014 | K131790 | A9800 ANESTHESIA WORKSTATION | BSZ | Substantially Equivalent | Oricare, Inc. | accessdata.fda.gov |
| April 25, 2012 | K113485 | ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Shenzhen Carewell Electronics Co., Ltd. | accessdata.fda.gov |
| September 8, 2011 | K112329 | OMNI PATIENT MONITOR | MWI | Substantially Equivalent | Infinium Medical | accessdata.fda.gov |
| June 2, 2011 | K103737 | OMNI II PATIENT MONITOR | MWI | Substantially Equivalent | Infinium Medical | accessdata.fda.gov |
| November 23, 2010 | K103268 | OMNI EXPRESS | MWI | Substantially Equivalent | Infinium Medical | accessdata.fda.gov |
| August 11, 2010 | K101052 | OMNI III PATIENT MONITOR | MWI | Substantially Equivalent | Infinium Medical | accessdata.fda.gov |
| October 3, 2001 | K012446 | OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI | BSZ | Substantially Equivalent | Charles A. Smith | accessdata.fda.gov |
| August 23, 2000 | K000859 | OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 | BSZ | Substantially Equivalent | Charles A. Smith | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 31, 2019 | 82999 | Class II | Ongoing | CLEO Patient Monitor /Tranquility VS Patient Monitor | The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option. | accessdata.fda.gov |
Compare with other makers
- All makers of Laryngoscope, Rigid
- All makers of System, Thermal Regulating
- All makers of Table, Examination, Medical, Powered
- All makers of Gas-Machine, Anesthesia
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
Updated September 11, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.