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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Tsolution One Surgical System - M9461005730

CT MOTION ROD 30
THINK SURGICAL, INC.
100573
In Commercial Distribution

  • M9461005730 ()

  • Length: 30 Inch


  • Robotic surgical arm system

Bioserenity Cloud - 03615220004270

Bioserenity CLOUD is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals.
BIOSERENITY MEDICAL DEVICES GROUP
1012-21002-US
Not in Commercial Distribution

  • 03615220004270 ()


  • Bio-energy preliminary diagnosis system application software

Symani Surgical Robot Console Flat - 08055713170511

An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.
MEDICAL MICROINSTRUMENTS, INC.
CNS-000
In Commercial Distribution

  • 08055713170511 ()


  • Robotic surgical arm system

Symani Surgical Robot Console - 08055713170504

An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.
MEDICAL MICROINSTRUMENTS, INC.
CNS-100
In Commercial Distribution

  • 08055713170504 ()


  • Robotic surgical arm system

Symani Surgical Robot CMM Plug type "B" - 08055713170146

An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.
MEDICAL MICROINSTRUMENTS, INC.
CMM-B010
In Commercial Distribution

  • 08055713170146 ()


  • Robotic surgical arm system

CoBot - 03701311500322

No Description
ECENTIAL ROBOTICS
I00019
In Commercial Distribution

  • 03701311500322 ()


  • Robotic surgical arm system

OmnisEMG - B179OMNI13E87E4

Biomechanical function analysis / interactive rehabilitation system
ACCELERATED CARE PLUS CORP
44144
In Commercial Distribution

  • B179OMNI13E87E4 ()


  • Biomechanical function analysis/interactive rehabilitation system

Dexter L6 Robot - 07640184840516

Dexter L6 - Patient Cart 1 Dexter L6 - Patient Cart 2 Dexter L6 - Surgeon Console
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840516 ()
710

  • Robotic surgical arm system

Dexter Monopolar Hook - 07640184840493

Dexter L6 Monopolar Hook
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840509 ()
  • 07640184840493 ()
709

  • Robotic surgical arm system

Dexter Monopolar Scissors - 07640184840479

Dexter L6 Monopolar Scissors
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840486 ()
  • 07640184840479 ()
707

  • Robotic surgical arm system

Dexter Bipolar Johann Grasper - 07640184840431

Dexter L6 Bipolar Johann Grasper
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840448 ()
  • 07640184840431 ()
703

  • Robotic surgical arm system

Dexter Bipolar Maryland Dissector - 07640184840417

Dexter L6 Bipolar Maryland Dissector
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840424 ()
  • 07640184840417 ()
701

  • Robotic surgical arm system

Dexter Sterile Interface - 07640184840233

Dexter L6 Sterile Interface
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840240 ()
  • 07640184840233 ()
140

  • Robotic surgical arm system

Dexter L6 Endoscope Cart - 07640184840219

Dexter L6 Endoscope Cart
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840226 ()
  • 07640184840219 ()
339

  • Robotic surgical arm system

Dexter L6 Incision Pointer - 07640184840172

Dexter L6 Incision Pointer
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840189 ()
  • 07640184840172 ()
413

  • Robotic surgical arm system

Dexter L6 Handle Grip - 07640184840158

Dexter L6 Handle Grip
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840158 ()
  • 07640184840165 ()
146

  • Robotic surgical arm system

Dexter L6 Accessory tray - 07640184840134

Dexter L6 Accessory tray
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840141 ()
  • 07640184840134 ()
147

  • Robotic surgical arm system

Dexter Needle Holder - 07640184840455

Dexter L6 Needle Holder
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840462 ()
  • 07640184840455 ()
705

  • Robotic surgical arm system

Dexter L6 Emergency Release Tool - 07640184840196

Dexter L6 Emergency Release Tool
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840400 ()
  • 07640184840196 ()
487

  • Robotic surgical arm system

Monarch Platform, Bronchoscopy 4.1 - 10810068810988

The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
AURIS HEALTH, INC.
MON-000008
In Commercial Distribution

  • 20810068810985 ()
  • 10810068810988 ()


  • Robotic surgical arm system

Monarch Bronchscope 2.0/Monarch Platform (P2) - 10810068810803

The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. Monarch Bronchscope 2.0/Monarch Platform (P2)
AURIS HEALTH, INC.
MON-000006
In Commercial Distribution

  • 10810068810803 ()
  • 20810068810800 ()


  • Robotic surgical arm system

ACE - 07290017702254

XACT ACE Robotic System
XACT ROBOTICS LTD
D
In Commercial Distribution

  • 07290017702254 ()
XR-ACE-SYS

  • Robotic surgical arm system

XACT ACE Robot - 07290017702018

XACT ACE Robot
XACT ROBOTICS LTD
B
In Commercial Distribution

  • 07290017702018 ()
XR-ACE-RBT

  • Robotic surgical arm system

RI Hip Navigation - 00885556806609

RI.HIP NAVIGATION CORI SERVICE KIT
Smith & Nephew, Inc.
ROB20024
In Commercial Distribution

  • 00885556806609 ()
ROB20024

  • Robotic surgical arm system

RI Hip Navigation Cori - 00885556806548

RI.HIP NAVIGATION CORI USA LATAM APAC BUNDLE
Smith & Nephew, Inc.
ROB20018
In Commercial Distribution

  • 00885556806548 ()
ROB20018

  • Robotic surgical arm system

Real Intelligence - 00885556917435

RI.KNEE ROBOTICS V3.0
Smith & Nephew, Inc.
ROB20040
In Commercial Distribution

  • 00885556917435 ()
ROB20040

  • Robotic surgical arm system

REAL INTELLIGENCE - 00885556780862

REAL INTELLIGENCE TRACKING CAMERA
Smith & Nephew, Inc.
ROB10025S
In Commercial Distribution

  • 00885556780862 ()
ROB10025S

  • Robotic surgical arm system

REAL INTELLIGENCE - 00885556780855

REAL INTELLIGENCE CORI
Smith & Nephew, Inc.
ROB10024S
In Commercial Distribution

  • 00885556780855 ()
ROB10024S

  • Robotic surgical arm system

REAL INTELLIGENCE - 00885556798034

RI.HIP NAVIGATION ON CORI INSTALLER1.0.1
Smith & Nephew, Inc.
ROB10406
In Commercial Distribution

  • 00885556798034 ()
ROB10406

  • Robotic surgical arm system

REAL INTELLIGENCE - 00885556798027

R.I.KNEE 2.1 SOFTWARE KIT
Smith & Nephew, Inc.
ROB10405
In Commercial Distribution

  • 00885556798027 ()
ROB10405

  • Robotic surgical arm system
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