Flight Medical Innovations Ltd.
PETACH TIKVA Central, IL
FLIGHT MEDICAL INNOVATIONS LTD. appears in FDA device records in PETACH TIKVA Central, IL. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Flight Medical Innovations Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Flight Medical , Ltd.510(k), recall
510(k) clearance history
FDA records hold 6 510(k) clearances for Flight Medical Innovations Ltd. between 2010 and 2024. The busiest year on record is 2010, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223120 | Ventoux VC2; Ventoux VC3 | CBK | Substantially Equivalent | |
| K143035 | Flight 60 Ventilator | CBK | Substantially Equivalent | |
| K130171 | FLIGHT 60 VENTILATOR | CBK | Substantially Equivalent | |
| K120726 | FLIGHT 60 VENTILATOR | CBK | Substantially Equivalent | |
| K111683 | FLIGHT 60 VENTILATOR | CBK | Substantially Equivalent | |
| K100753 | FLIGHT 60 VENTILATOR, MODEL F-60 | CBK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003135857 | 3003135857 | FLIGHT MEDICAL INNOVATIONS LTD. | 7 HATNUFA ST., PETACH TIKVA Central 4951025 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BTCBag, Reservoir
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- NNIContainer, Specimen, Non-Sterile
- NOUContinuous, Ventilator, Home Use
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- PCMPortable Liquid Oxygen Unit Stand
- BZOSet, Tubing And Support, Ventilator (W Harness)
- JAYSupport, Breathing Tube
- CBKVentilator, Continuous, Facility Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1041-2012 | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain