Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of MedtronicLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Given Imaging with 31 510(k) clearances and 2 device recalls. The most recent is a device recall dated Aug 6, 2026: Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 6, 2026 | Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. UClass I · Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalat | Device recalls |
| Jun 3, 2025 | Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidaClass I · It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Spe | Device recalls |
| May 10, 2024 | PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareK240276 · NEZ | 510(k) clearances |
| Jun 30, 2023 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EK230991 · NEZ | 510(k) clearances |
| Aug 27, 2021 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EK211684 · NEZ | 510(k) clearances |
| Mar 8, 2018 | PillCam Patency SystemK180171 · NSI | 510(k) clearances |
| Sep 1, 2017 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0K170210 · NEZ | 510(k) clearances |
| May 26, 2017 | RAPID WebK170839 · NEZ | 510(k) clearances |
| Apr 28, 2016 | ManoScan SystemK151086 · FFX | 510(k) clearances |
| Jan 14, 2016 | PillCam COLON 2 Capsule Endoscopy SystemK153466 · PGD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
