FDA Device Intelligence
HomeBest Nomos › Needle Kit, TargetScan 2, 18 Gauge, Single

Needle Kit, TargetScan 2, 18 Gauge, Single

Best Nomos · Model 015-A200 · UDI-DI 00852656007441

ITXFCG
1
510(k) clearances
4,015
Adverse events (23 deaths)
147
Recalls
396
Facilities

Description

The TargetScan needles are used in conjunction with the biopsy planning feature of the Targetscan System to target the prostate biopsy locations created in a biopsy plan.

Recalls

DateFirmReason
2025-11-17Sheathing Technologies IncVaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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 docs
Data 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.