Data / Medical devices / Israel / Flight Medical Innovations Ltd.
Flight Medical Innovations Ltd.: FDA-registered device maker in PETACH TIKVA Central, Israel, 6 510(k) clearances
Flight Medical Innovations Ltd. is registered with the FDA (registration 3003135857) in PETACH TIKVA Central, Israel. It lists 9 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 2, 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
- 3003135857
- Address
- 7 Hatnufa ST., PETACH TIKVA Central, Israel, 4951025
- Owner or operator
- Flight Medical Innovations Ltd (9046407)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- May 14, 2008
- Registered through
- 2026
- Brand names listed
- F60 DL Flow Sensor Kit, F60 DL Ped Flow Sensor Kit, F60 DL Ped Single Use PC RD, F60 DL Single Use PC, F60 DL Single Use Ped PC, F60 Ped DL Flow Sensor Kit RD, F60 Ped. SL FS Kit RD, F60 Quick Release Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Reservoir | BTC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Continuous, Ventilator, Home Use | NOU | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer | accessdata.fda.gov |
| Portable Liquid Oxygen Unit Stand | PCM | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Support, Breathing Tube | JAY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| December 2, 2024 | K223120 | Ventoux VC2; Ventoux VC3 | CBK | Substantially Equivalent | Flight Medical Innovations , Ltd. | accessdata.fda.gov |
| March 30, 2016 | K143035 | Flight 60 Ventilator | CBK | Substantially Equivalent | Flight Medical Innovations , Ltd. | accessdata.fda.gov |
| April 8, 2014 | K130171 | FLIGHT 60 VENTILATOR | CBK | Substantially Equivalent | Flight Medical Innovations , Ltd. | accessdata.fda.gov |
| July 6, 2012 | K120726 | FLIGHT 60 VENTILATOR | CBK | Substantially Equivalent | Flight Medical Innovations , Ltd. | accessdata.fda.gov |
| October 31, 2011 | K111683 | FLIGHT 60 VENTILATOR | CBK | Substantially Equivalent | Flight Medical Innovations , Ltd. | accessdata.fda.gov |
| August 20, 2010 | K100753 | FLIGHT 60 VENTILATOR, MODEL F-60 | CBK | Substantially Equivalent | Flight Medical , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 10, 2011 | 59827 | Not yet classified | Terminated | V24-00400-29 cable, an accessory to the Newport HT50 ventilator. The V24-00400-29 cable is an accessory to the Newport HT50 ventilator intended to transfer the alarm signal from the ventilator to a nurse remote station. | The recall was initiated because Flight Medical Innovations Ltd. has identified a problem may occur when contact between an exposed unused wire and the grounding wire occurs. If this contact occurs the ventilator may reset and switch off. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Bag, Reservoir
- All makers of Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- All makers of Continuous, Ventilator, Home Use
- All makers of Ventilator, Continuous, Facility Use
- All makers of Portable Liquid Oxygen Unit Stand
Updated December 2, 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.