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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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FLEX - 00850190004513

Flex Case Kit- Option 7
MEDROBOTICS CORPORATION
25327
In Commercial Distribution

  • 00850190004513 ()


  • Robotic surgical arm system

Flex - 00850190004193

3D Camera
MEDROBOTICS CORPORATION
25386
In Commercial Distribution

  • 20850190004197 ()
  • 00850190004193 ()


  • Robotic surgical arm system

Flex - 00850190004124

TA Instrument Support
MEDROBOTICS CORPORATION
25173
In Commercial Distribution

  • 00850190004124 ()
  • 10850190004121 ()


  • Robotic surgical arm system

FLEX - 00850190004070

FLEX STAND
MEDROBOTICS CORPORATION
23157
In Commercial Distribution

  • 00850190004070 ()


  • Robotic surgical arm system

FLEX - 00850190004032

FLEX CONSOLE
MEDROBOTICS CORPORATION
24699
In Commercial Distribution

  • 00850190004032 ()


  • Robotic surgical arm system

MJS System 3 Upgrade - 00718175004050

BIODEX SYSTEM 3 REMANUFACTURE
BIODEX MEDICAL SYSTEMS, INC.
850-820
Not in Commercial Distribution

  • 00718175004050 ()
850-820

  • Biomechanical function analysis/interactive rehabilitation system

mTrigger - 00863712000337

mTrigger Biofeedback System
MTRIGGER, LLC
BI2612/BK2613
In Commercial Distribution

  • 00863712000337 ()


  • Biomechanical function analysis/interactive rehabilitation system

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

CLINICAL PC - 00889024511354

No Description
Orthosoft Inc
20-8020-050-01
In Commercial Distribution

  • 00889024511354 ()
20-8020-050-01

  • Robotic surgical arm system

ROSA® KNEE OPTICAL UNIT - 00889024511323

No Description
Orthosoft Inc
20-8020-120-01
In Commercial Distribution

  • 00889024511323 ()
20-8020-120-01

  • Robotic surgical arm system

ROSA® Recon - 00889024511170

Platform
Orthosoft Inc
20-8020-110-01
In Commercial Distribution

  • 00889024511170 ()
20-8020-110-01

  • Robotic surgical arm system

ROSA® Recon Platform - 00889024511026

No Description
Orthosoft Inc
20-8020-100-01
In Commercial Distribution

  • 00889024511026 ()
20-8020-100-01

  • Robotic surgical arm system

Monarch Advanced Imaging Accessory Kit - B634MON0007090

Window Field Generator, Connection Cable, Mounting System
AURIS HEALTH, INC.
MON-000709
In Commercial Distribution

  • B634MON0007091 ()
  • B634MON0007090 ()
MON-000709

  • Robotic surgical arm system

Monarch Bronchscope 2.0/Monarch Platform (P2) - B634MON0000060

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

  • B634MON0000060 ()


  • Robotic surgical arm system

Monarch™ Platform (Refurbished) - B634MON000005R0

The Monarch Platform (Refurbished) enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
AURIS HEALTH, INC.
MON000005R
In Commercial Distribution

  • B634MON000005R0 ()
MON000005R

  • Robotic surgical arm system

Monarch Endoscopy Platform (P1) System, Refurbished - B634MON00000501R0

Monarch Endoscopy Platform (P1) System, Refurbished
AURIS HEALTH, INC.
MON-000005-01R
In Commercial Distribution

  • B634MON00000501R0 ()


  • Robotic surgical arm system

Monarch Endoscopy Platform (P1) Tower Upgrade - B634MON000005010

Monarch Endoscopy Platform (P1) Tower Upgrade
AURIS HEALTH, INC.
MON-000005-01
In Commercial Distribution

  • B634MON000005010 ()


  • Robotic surgical arm system

Monarch Endoscopy Platform (P1) Tower Upgrade - B634MON00000501

Monarch Endoscopy Platform (P1) Tower Upgrade
AURIS HEALTH, INC.
MON-000005-01
Not in Commercial Distribution

  • B634MON00000501 ()


  • Robotic surgical arm system

Monarch™ Platform - B634MON0000050

The Monarch Platform enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
AURIS HEALTH, INC.
MON000005
In Commercial Distribution

  • B634MON0000050 ()
MON000005

  • Robotic surgical arm 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 Needle Holder - 07640184840455

Dexter L6 Needle Holder
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840462 ()
  • 07640184840455 ()
705

  • 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 Emergency Release Tool - 07640184840196

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

  • 07640184840400 ()
  • 07640184840196 ()
487

  • 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

Tsolution One Surgical System - M9461082000

ASSEMBLY, TCAT™ 200, 100-240V
THINK SURGICAL, INC.
108200
In Commercial Distribution

  • M9461082000 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076660

REAMER DRIVER, ACETABULAR CUP, 001
THINK SURGICAL, INC.
107666
In Commercial Distribution

  • M9461076660 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076650

REAMER DRIVER SLEEVE
THINK SURGICAL, INC.
107665
In Commercial Distribution

  • M9461076650 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076500

BEARING SLEEVE, IMPACTOR
THINK SURGICAL, INC.
107650
In Commercial Distribution

  • M9461076500 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076490

BEARING SLEEVE, REAMER DRIVER
THINK SURGICAL, INC.
107649
In Commercial Distribution

  • M9461076490 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076450

CUTTER DRIVE ASSEMBLY, TCAT
THINK SURGICAL, INC.
107645
In Commercial Distribution

  • M9461076450 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076440

REAMER/IMPACTOR HOLDER
THINK SURGICAL, INC.
107644
In Commercial Distribution

  • M9461076440 ()


  • Robotic surgical arm system
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