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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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Apollo Knee - 05056139245145

Femur Bone Fixation Base
CORIN LTD
TKR.IN.1800
In Commercial Distribution

  • 05056139245145 ()


  • Robotic surgical arm system

Apollo Knee - 05056139245077

Femoral Paddle, Large Left B
CORIN LTD
TKR.BB.1707
In Commercial Distribution

  • 05056139245077 ()


  • Robotic surgical arm system

Apollo Knee - 05056139245060

Femoral Paddle, Large Right B
CORIN LTD
TKR.BB.1706
In Commercial Distribution

  • 05056139245060 ()


  • Robotic surgical arm system

Apollo Knee - 05056139245053

Femoral Paddle, Large Left A
CORIN LTD
TKR.BB.1705
In Commercial Distribution

  • 05056139245053 ()


  • Robotic surgical arm system

Apollo Knee - 05056139245039

Femoral Paddle, Large Right A
CORIN LTD
TKR.BB.1704
In Commercial Distribution

  • 05056139245039 ()


  • Robotic surgical arm system

Apollo Knee - 05056139245022

Femoral Paddle, Small Left B
CORIN LTD
TKR.BB.1703
In Commercial Distribution

  • 05056139245022 ()


  • Robotic surgical arm system

Apollo Knee - 05056139245015

Femoral Paddle, Small Right B
CORIN LTD
TKR.BB.1702
In Commercial Distribution

  • 05056139245015 ()


  • Robotic surgical arm system

Apollo Knee - 05056139245008

Femoral Paddle, Small Left A
CORIN LTD
TKR.BB.1701
In Commercial Distribution

  • 05056139245008 ()


  • Robotic surgical arm system

Apollo Knee - 05056139244995

Femoral Paddle, Small Right A
CORIN LTD
TKR.BB.1700
In Commercial Distribution

  • 05056139244995 ()


  • Robotic surgical arm system

Apollo Knee - 05056139244988

Universal Reattachable Joint Ø6.9mm Adaptor
CORIN LTD
TKR.IN.1700
In Commercial Distribution

  • 05056139244988 ()


  • Robotic surgical arm system

Apollo Knee - 05056139244971

Dual Post Two Pin Universal Fixation
CORIN LTD
TKR.IN.1600
In Commercial Distribution

  • 05056139244971 ()


  • Robotic surgical arm system

Apollo Knee - 05056139244940

Apollo BalanceBot Tibial Tray Trial Assembly - Large Left
CORIN LTD
TKR.BB.1403
In Commercial Distribution

  • 05056139244940 ()


  • Robotic surgical arm system

Apollo Knee - 05056139244933

Apollo BalanceBot Tibial Tray Trial Assembly - Large Right
CORIN LTD
TKR.BB.1402
In Commercial Distribution

  • 05056139244933 ()


  • Robotic surgical arm system

Apollo Knee - 05056139244926

Apollo BalanceBot Tibial Tray Trial Assembly - Small Left
CORIN LTD
TKR.BB.1401
In Commercial Distribution

  • 05056139244926 ()


  • Robotic surgical arm system

MIRA - 00850038042028

No Description
Virtual Incision Corporation
180-020000-000
In Commercial Distribution

  • 00850038042028 ()


  • Robotic surgical arm system

MIRA - 00850038042004

No Description
Virtual Incision Corporation
180-000000-000
In Commercial Distribution

  • 00850038042004 ()
MIRA-REP-MB1

  • 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

CoBot - 03701311500322

No Description
ECENTIAL ROBOTICS
I00019
In Commercial Distribution

  • 03701311500322 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982302320

Cranial Drill, Ø6.00mm
GLOBUS MEDICAL, INC.
6143.1870S
In Commercial Distribution

  • 00193982302320 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982302269

Cranial Drill with Stop, Ø3.20mm
GLOBUS MEDICAL, INC.
6143.1842S
In Commercial Distribution

  • 00193982302269 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982302238

Cranial Drill with Stop, Ø2.40mm
GLOBUS MEDICAL, INC.
6143.1834S
In Commercial Distribution

  • 00193982302238 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192686

Trajectory Probe, GPS
GLOBUS MEDICAL, INC.
6143.1938
In Commercial Distribution

  • 00193982192686 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192679

Surveillance Marker Holder
GLOBUS MEDICAL, INC.
6143.1934
In Commercial Distribution

  • 00193982192679 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192662

Electrode Drive Clamp
GLOBUS MEDICAL, INC.
6143.1933
In Commercial Distribution

  • 00193982192662 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192655

Cranial Dynamic Reference Base
GLOBUS MEDICAL, INC.
6143.1932
In Commercial Distribution

  • 00193982192655 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192648

Cranial Articulating Arm
GLOBUS MEDICAL, INC.
6143.1931
In Commercial Distribution

  • 00193982192648 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192631

Intraoperative CT Registration Clamp
GLOBUS MEDICAL, INC.
6143.1930
In Commercial Distribution

  • 00193982192631 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192624

3-Pin Fixation Adapter
GLOBUS MEDICAL, INC.
6143.1925
In Commercial Distribution

  • 00193982192624 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192617

CRW Frame Reference Array
GLOBUS MEDICAL, INC.
6143.1923
In Commercial Distribution

  • 00193982192617 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192600

CRW Frame Base Adapter
GLOBUS MEDICAL, INC.
6143.1922
In Commercial Distribution

  • 00193982192600 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192594

Leksell Frame Reference Array
GLOBUS MEDICAL, INC.
6143.1921
In Commercial Distribution

  • 00193982192594 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192587

Leksell Frame Base Adapter
GLOBUS MEDICAL, INC.
6143.1920
In Commercial Distribution

  • 00193982192587 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192570

End Effector Guide Tube, 10.0mm
GLOBUS MEDICAL, INC.
6143.1780
In Commercial Distribution

  • 00193982192570 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192563

End Effector Guide Tube, 6.35mm
GLOBUS MEDICAL, INC.
6143.1743
In Commercial Distribution

  • 00193982192563 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192556

End Effector Guide Tube, 3.2mm
GLOBUS MEDICAL, INC.
6143.1712
In Commercial Distribution

  • 00193982192556 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192549

End Effector Guide Tube, 2.4mm
GLOBUS MEDICAL, INC.
6143.1704
In Commercial Distribution

  • 00193982192549 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192532

End Effector Guide Tube, 2.3mm
GLOBUS MEDICAL, INC.
6143.1703
In Commercial Distribution

  • 00193982192532 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192518

End Effector Guide Tube, 1.8mm
GLOBUS MEDICAL, INC.
6143.1698
In Commercial Distribution

  • 00193982192518 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192365

2.5mm Hex Driver
GLOBUS MEDICAL, INC.
6143.1827
In Commercial Distribution

  • 00193982192365 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982192358

Cranial Drill Stop
GLOBUS MEDICAL, INC.
6143.1826
In Commercial Distribution

  • 00193982192358 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982185220

Patient Stabilization Stand
GLOBUS MEDICAL, INC.
6143.2505
In Commercial Distribution

  • 00193982185220 ()


  • Robotic surgical arm system

EXCELSIUS GPS - 00193982143473

Interchangeable Guide End Effector
GLOBUS MEDICAL, INC.
6143.2504
In Commercial Distribution

  • 00193982143473 ()


  • Robotic surgical arm system

Micromate - 09010279000411

The intended use of the Micromate™ device is to function as a remote-operated positioning and guidance system during interventional procedures. Positioning is done in a remote-controlled manner; planning of the position/angulation is done based on 2D/3D patient data (CT, cone-beam CT, fluoroscopy) by external/internal planning software – for example using an image-guided navigation system or external/internal navigation system, or planning software coming with the used imaging device. Also, verification of the correct position and orientation of the tool prior to/during/after the intervention is done by means of these external devices. The Micromate™ system is then acting as a guideway during the manual insertion of the interventional tool – usually a needle type device, and the like - through a third-party needle guide, manufactured by Exact MM (K101689): P/N E2178 (Micromate Needle Guide Set, 8-11G), P/N E2183 (Micromate Needle Guide Set,10-14G) and P/N E2184 (Micromate Needle Guide Set, 15-21G). During operation, the device is covered with a sterile drape, which is part of the P/N2178, P/N E2183 and E2184. An additional third-party Control Unit Drape is available, also manufactured by Exact MM (K101689): P/N 11718EU (Micromate Control Unit Drape). Applications include, but are not limited to, interventions like biopsy procedures, tumor ablation, nerve blocking, electrode placement, etc.
iSYS Medizintechnik GmbH
iONE
In Commercial Distribution

  • 09010279000411 ()


  • Robotic surgical arm system

mTrigger - 00863712000337

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

  • 00863712000337 ()


  • Biomechanical function analysis/interactive rehabilitation 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

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

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
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