GE
Pharmaceutical company. FDA files no records under this name; these are its 76 companies' records, each linked to the record.
- Records across the group: 2,738, 77 entitiesAI
- 510(k) clearances: 1,551
- Device recalls: 1,003
- AI-enabled devices: 126
- Drug applications: 54
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, GE and its 76 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Oct 26, 2026 | MIM KineticIDK261763 · LLZ | 510(k) clearances |
| Oct 2, 2026 | Lung GuidanceK261042 · QJU | 510(k) clearances |
| Sep 16, 2026 | EchoPAC Software Only / EchoPAC Plug-in (v211)K261623 · QIH | 510(k) clearances |
| Sep 2, 2026 | Vivid Explorer/Vivid Advanced/Vivid FocusK261313 · IYN | 510(k) clearances |
| Sep 1, 2026 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MK260656 · MHX | 510(k) clearances |
| Aug 28, 2026 | Carescape Canvas 1000; Carescape Canvas Smart DisplayK260343 · MHX | 510(k) clearances |
| Aug 13, 2026 | AIR Recon DLK253808 · LNH | 510(k) clearances |
| Jul 30, 2026 | LOGIQ FocusK261835 · IYN | 510(k) clearances |
| Jun 24, 2026 | Enhanced Boundary for PCCTK253560 · Radiology | AI-enabled devices |
| Apr 14, 2026 | Critical Care Suite with Enteric Tube Positioning AI AlgorithmK253502 · Radiology | AI-enabled devices |
| Mar 27, 2026 | Automated Aortic Stenosis Software (AutoAS)K254161 · Radiology | AI-enabled devices |
| Mar 27, 2026 | Contour ProtégéAI+K253270 · Radiology | AI-enabled devices |
| Mar 24, 2026 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerK260673 · Radiology | AI-enabled devices |
| Mar 23, 2026 | True Definition DLK253686 · Radiology | AI-enabled devices |
| Mar 20, 2026 | Photonova Spectra, Photonova Spectra SelectK253520 · Radiology | AI-enabled devices |
| Feb 6, 2026 | SIGNA BoltK253780 · Radiology | AI-enabled devices |
| Oct 29, 2018 | Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE HealthClass II · Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack | Drug recalls |
| Feb 18, 2013 | Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammogClass II · It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared inco | Device recalls |
Subsidiaries and Divisions
76 firms in the GE group, most records first- GE Healthcare850 records
- GE Medical Systems528 records
- Ohmeda Medical136 records
- Datex-Ohmeda135 records
- GE Medical Systems Ultrasound and Primary Care Diagnostics125 records
- Amersham94 records
- Marquette Electronics, Inc.82 records
- GE OEC Medical Systems66 records
- GE Medical Systems SCS64 records
- USA Instruments64 records
- GE Healthcare Finland Oy55 records
- GE Medical Systems Israel, Functional Imaging47 records
- Diasonics, Inc.42 records
- GE Medical Systems China39 records
- General Electric Medical Systems Information Techn33 records
- MIM Software31 records
- Marquette Medical Systems26 records
- BK Medical ApS22 records
- GE Healthcare Japan Corporation22 records
- CGR Medical20 records
- GE Medical Systems Israel17 records
- GE Vingmed Ultrasound17 records
- Wipro GE Healthcare15 records
- GE Hangwei Medical Systems Co., Ltd.15 records
- GE Hualun Medical Systems14 records
- Medi-Physics, Inc.13 records
- Caption Health12 records
- GE Healthcare Coils12 records
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LL12 records
- Data Critical Corporation11 records
- Datex-Engstrom10 records
- Ge Medical Systems Ultrasound And8 records
- U-Systems8 records
- Ge Medical Systems Ultrasound and Primary Care Dia7 records
- General Electric Medical Systems6 records
- Corometrics Medical Systems5 records
- Datex Medical Instrumentation5 records
- GE Healthcare Integrated IT Solutions4 records
- Ge Medical System Israel , Ltd.4 records
- Ge Medical Systems Israel , Ltd.4 records
- Bay Labs, Inc.3 records
- GE Lunar3 records
- GE Medical Systems Israel Ultrasound3 records
- Instrumentarium Corp. Imaging Division3 records
- Vingmed Sound3 records
- Vital Signs Devices3 records
- E for M Imaging Systems, Marquette Electronics2 records
- GE Healthcare Dynamic Imaging Solutions2 records
- GE Healthcare Information Technologies2 records
- GE Healthcare Ireland2 records
- GE Hungary Kft2 records
- Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc2 records
- Ge Medical Syst. Information Technologies2 records
- GE Medical Systems Lunar2 records
- Instrumentarium-Datex2 records
- Ohmeda Anesthesia Systems2 records
- Amersham Health1 records
- GE Healthcare Austria GmbH & Co1 records
- GE Healthcare Biosciences1 records
- GE Healthcare Clinical Systems1 records
Canada and Imports
Across the GE group, matched by company nameNames and Identifiers
- Appears as
- Website
- ge.com
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