Home › Device types › FFT
Electrode, Ph, Stomach
FDA product code FFT · Class 1 · Gastroenterology, Urology
109
Registered devices
12,853
Adverse events
10
Recalls
49
510(k) clearances
Devices with this code
Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Versaflex — Given Imaging, Inc.Versaflex — Given Imaging, Inc.1 channel pH antimony, 6.4 Fr — Medical Measurement Systems B.V.Bravo — Given Imaging, Inc.Versaflex — Given Imaging, Inc.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Versaflex — Given Imaging, Inc.Bravo — Given Imaging, Inc.Reflux — Given Imaging, Inc.Bravo — Given Imaging, Inc.Versaflex — Given Imaging, Inc.Versaflex — Given Imaging, Inc.Restech — The Reflux CompanyalpHaONE — Chongqing Jinshan Science & Technology (Group) Co., LtdBravo — Given Imaging, Inc.Versaflex — Given Imaging, Inc.2 channel pH antimony, 10 cm spacing, 6.4 Fr — Medical Measurement Systems B.V.Diversatek Healthcare — DIVERSATEK HEALTHCARE, INC.Versaflex — Given Imaging, Inc.Bravo — Given Imaging, Inc.alpHaONE — Chongqing Jinshan Science & Technology (Group) Co., LtdalpHaONE — Chongqing Jinshan Science & Technology (Group) Co., Ltd2 channel pH antimony, 5 cm spacing, 6.4 Fr — Medical Measurement Systems B.V.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-03 | Given Imaging Ltd. | It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may p |
| 2021-02-26 | Covidien Llc | The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate |
| 2021-02-26 | Covidien Llc | The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate |
| 2016-04-15 | Covidien LLC | Potential of an allergic reaction in a patient with nickel sensitivity. |
| 2016-04-15 | Covidien LLC | Potential of an allergic reaction in a patient with nickel sensitivity. |
| 2007-12-03 | Medtronic Neuromodulation | Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall. |
| 2006-01-25 | Medtronic Gastroenterology / Urology | Lot 0001491 has a manufacturing defect in the sensor spacing. Sensors have been placed 5 cm apart instead of 15 cm apart. Medtronic has determined that patien |
| 2005-12-09 | Medtronic Gastroenterology / Urology | Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the Digitrapper pH recorder. Me |
| 2003-09-24 | Sandhill Scientific, Inc | Pouch containing pediatric probes was labeled as containing adult probes. |
| 2003-01-08 | Sandhill Scientific, Inc | Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.