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Needle Guide
CIVCO MEDICAL INSTRUMENTS CO., INC. · Model 810-401 · UDI-DI 10841436123249
1
510(k) clearances
4,104
Adverse events (23 deaths)
147
Recalls
397
Facilities
Description
Sterile endocavity needle guide for use with International Biomedical E717 6.5 MHz, Mindray 65EB10EA, 6CV1, 6CV1s, EV6.5Mhz/R10, V10-4, V10-4s, V11-3s, V11-3Ws, Samsung Medison EC4-9ES, EC4-9IS, ER4-9ES, Siemens 6.5EC10, SuperSonic E12-3, SE12-3, SEV12-3 transducers One-cell MEA: =80% embryo developed to expand cytoblast at 96 hours USP Endotoxin (LAL) tested and passed with 20 EU or less per device.
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.