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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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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
AURIS HEALTH, INC.
MON-000005-01
Not in Commercial Distribution

  • B634MON00000501 ()


  • Robotic surgical arm system
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
ASSEMBLY, TCAT™ 200, 100-240V
THINK SURGICAL, INC.
108200
In Commercial Distribution

  • M9461082000 ()


  • Robotic surgical arm system
REAMER DRIVER, ACETABULAR CUP, 001
THINK SURGICAL, INC.
107666
In Commercial Distribution

  • M9461076660 ()


  • Robotic surgical arm system
REAMER DRIVER SLEEVE
THINK SURGICAL, INC.
107665
In Commercial Distribution

  • M9461076650 ()


  • Robotic surgical arm system
BEARING SLEEVE, IMPACTOR
THINK SURGICAL, INC.
107650
In Commercial Distribution

  • M9461076500 ()


  • Robotic surgical arm system
BEARING SLEEVE, REAMER DRIVER
THINK SURGICAL, INC.
107649
In Commercial Distribution

  • M9461076490 ()


  • Robotic surgical arm system
CUTTER DRIVE ASSEMBLY, TCAT
THINK SURGICAL, INC.
107645
In Commercial Distribution

  • M9461076450 ()


  • Robotic surgical arm system
REAMER/IMPACTOR HOLDER
THINK SURGICAL, INC.
107644
In Commercial Distribution

  • M9461076440 ()


  • Robotic surgical arm system
COUPLER, MASTER SIDE
THINK SURGICAL, INC.
107642
In Commercial Distribution

  • M9461076420 ()


  • Robotic surgical arm system
ASSY, PERCUTANEOUS PROBE HUB
THINK SURGICAL, INC.
106382
In Commercial Distribution

  • M9461063820 ()


  • Robotic surgical arm system
THREADED DIGITIZER PROBE, BALL TIP
THINK SURGICAL, INC.
106298-04
In Commercial Distribution

  • M946106298040 ()


  • Robotic surgical arm system
THREADED DIGITIZER PROBE, TAPERED TROCHAR TIP
THINK SURGICAL, INC.
106298-03
In Commercial Distribution

  • M946106298030 ()


  • Robotic surgical arm system
HOFFMAN ADAPTER ROD
THINK SURGICAL, INC.
106219
In Commercial Distribution

  • M9461062190 ()


  • Robotic surgical arm system
SURGERY SUPPOR KIT, THA Cup US, 10 PACKS / CARTON
THINK SURGICAL, INC.
105934
In Commercial Distribution

  • M9461059340 ()


  • Robotic surgical arm system
TCAT THA Instrument Kit, Cup
THINK SURGICAL, INC.
105717
In Commercial Distribution

  • M9461057170 ()


  • Robotic surgical arm system
WRENCH, 2.5mm HEX, 465 SS
THINK SURGICAL, INC.
105716
In Commercial Distribution

  • M9461057160 ()

  • Width: 2.5 Millimeter


  • Robotic surgical arm system
ASSY, BEARING SLEEVE TCAT THA
THINK SURGICAL, INC.
105653
In Commercial Distribution

  • M9461056530 ()


  • Robotic surgical arm system
ASSEMBLY, BMM SMART PROBE, ADJUSTABLE
THINK SURGICAL, INC.
104948
In Commercial Distribution

  • M9461049480 ()


  • Robotic surgical arm system
No Description
THINK SURGICAL, INC.
103725
In Commercial Distribution

  • M9461037251 ()
103725

  • Robotic surgical arm system
CT MOTION ROD 42
THINK SURGICAL, INC.
103725
In Commercial Distribution

  • M9461037250 ()

  • Length: 42 Inch


  • Robotic surgical arm system
SHORT MARKER INSTALLATION TOOL
THINK SURGICAL, INC.
103593
In Commercial Distribution

  • M9461035930 ()


  • Robotic surgical arm system
No Description
THINK SURGICAL, INC.
103449
In Commercial Distribution

  • M9461034491 ()
103449

  • Robotic surgical arm system
CUTTER MOTOR
THINK SURGICAL, INC.
103426
In Commercial Distribution

  • M9461034260 ()


  • Robotic surgical arm system
ASSEMBLY, SWIVEL BLOCK
THINK SURGICAL, INC.
103414
In Commercial Distribution

  • M9461034140 ()


  • Robotic surgical arm system
CUTTER MOTOR CABLE
THINK SURGICAL, INC.
103384
In Commercial Distribution

  • M9461033840 ()


  • Robotic surgical arm system
ASSEMBLY, FIXATOR ARM, STRAIGHT
THINK SURGICAL, INC.
103205
In Commercial Distribution

  • M9461032050 ()


  • Robotic surgical arm system
ASSEMBLY, INSTALLATION VERIFICATION TOOLS
THINK SURGICAL, INC.
102940
In Commercial Distribution

  • M9461029400 ()


  • Robotic surgical arm system
CUTTER DRIVER PROBE
THINK SURGICAL, INC.
102709
In Commercial Distribution

  • M9461027090 ()


  • Robotic surgical arm system
CT MOTION ROD 30
THINK SURGICAL, INC.
100573
In Commercial Distribution

  • M9461005730 ()

  • Length: 30 Inch


  • Robotic surgical arm system
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
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
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
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
No Description
ECENTIAL ROBOTICS
I00019
In Commercial Distribution

  • 03701311500322 ()


  • Robotic surgical arm system
Biomechanical function analysis / interactive rehabilitation system
ACCELERATED CARE PLUS CORP
44144
In Commercial Distribution

  • B179OMNI13E87E4 ()


  • Biomechanical function analysis/interactive rehabilitation system
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 L6 Monopolar Hook
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840509 ()
  • 07640184840493 ()
709

  • Robotic surgical arm system
Dexter L6 Monopolar Scissors
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840486 ()
  • 07640184840479 ()
707

  • Robotic surgical arm system
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