제목1

제목2

Neurology/Neurointervention
FHC
STarDrive Encoder Motor System

Stereotaxic unit, non-frame

Item Name Stereotaxic unit, non-frame
Approval Number 수신24-869호
Approval Date 2024-05-16
Class 1
Manufacturer FHC, Inc.
관리자 2025-11-25 119
Orthopedics
LENTO
PtoleKnee Surgical Guide

Guide for medical use, invasive, single use

Item Name Guide for medical use, invasive, single use
Approval Number 수인25-4292호
Approval Date 2025-05-20
Class 2
Manufacturer Lento Medical Innovation, Inc.
관리자 2025-11-25 72
Neurology/Neurointervention
FHC
STarDrive Manual System

STarDrive Manual System

Item Name STarDrive Manual System
Approval Number 수신24-868호
Approval Date 2024-05-16
Class 1
Manufacturer FHC, Inc.
관리자 2025-11-25 72
Neurology/Neurointervention
FHC
Guideline 4000™ 5.0 System

Nerve locating system, battery-powered

Item Name Nerve locating system, battery-powered
Approval Number 수신25-4085호
Approval Date 2025-02-10
Class 2
Manufacturer FHC, Inc.
관리자 2025-11-25 98
Neurology/Neurointervention
FHC
microTargeting™ Electrodes

Electrode, cortical

Item Name Electrode, cortical
Approval Number 수신25-23호
Approval Date 2025-02-18
Class 4
Manufacturer FHC, Inc.
관리자 2025-11-25 89

C2AXXA1

Product Code C2AXXA1
Approval Number D 수인 25-4011호
Approval Date 2025-06-11
Class 2
Manufacturer Lento Medical Innovation, Inc.
관리자 2025-11-25 85