Home › Device types › ITX
Transducer, Ultrasonic, Diagnostic
FDA product code ITX · Class 2 · Radiology
8,827
Registered devices
3,948
Adverse events
147
Recalls
414
510(k) clearances
Devices with this code
ArcScan Insight 100 — ARCSCAN, INC.HITACHI — HITACHI, LTD.NA — MEDTRONIC XOMED, INC.GE Ultra-Pro II Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.HALYARD — OWENS & MINOR DISTRIBUTION, INC.Reusable Biopsy Bracket — PROTEK MEDICAL PRODUCTS, INC.Extension cable 2 MHz probe, monitoring — Compumedics Germany GmbH16 MHz probe, 3mm with adapter cable — Compumedics Germany GmbHSonosite ST — FUJIFILM SONOSITE, INC.Battery — FUJIFILM SONOSITE, INC.Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC.SonoScape — SONOSCAPE MEDICAL CORP.Hisense — Qingdao Hisense Medical Co., Ltd.SIUI — Shantou Institute of Ultrasonic Instruments Co., Ltd.SonoScape — SONOSCAPE MEDICAL CORP.Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.Sonata® Intrauterine Ultrasound Probe Return Kit — Gynesonics, Inc.CLEARTRACK PACKAGE — SAMSUNG MEDISON CO., LTD.Pathfinder Small Multi-Tool Instrument Clamp — ANALOGIC CORPORATIONVerza Guidance System — CIVCO MEDICAL INSTRUMENTS CO., INC.Exact Medical Manufacturing, Inc. — EXACT MEDICAL MANUFACTURING, INC.Hisense — Qingdao Hisense Medical Co., Ltd.Esaote Needle Guide Only Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-17 | Sheathing Technologies Inc | Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
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