FDA.reportPublic FDA data

Robotic surgical arm system

Definition
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.
GUDID devices
120
Last updated
2026-03-18 19:26:50

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00885556919712Real IntelligenceSmith & Nephew, Inc.ROB300012026-03-10
00885556919750Real IntelligenceSmith & Nephew, Inc.ROB300042026-03-10
00885556919774Real IntelligenceSmith & Nephew, Inc.ROB300062026-03-10
00885556924297Real IntelligenceSmith & Nephew, Inc.ROB308802026-03-10
05060548211226Versius Surgeon ConsoleCMR SURGICAL LIMITEDV-SS-10202026-03-09
05060548211233Versius Instrument Bedside UnitCMR SURGICAL LIMITEDV-SS-20202026-03-09
05060548211240Versius Visualisation Bedside UnitCMR SURGICAL LIMITEDV-SS-30202026-03-09
10884521826571Hugo RASCovidien LPMRASA00042026-01-09
10884521850859Hugo RASCovidien LPMRASC00012026-01-09
10884521850866Hugo RASCovidien LPMRASC00032026-01-09
10884521850880Hugo RASCovidien LPMRASC00022026-01-09
10884521851030Hugo RASCovidien LPMRASA00032026-01-09
10884521851047Hugo RASCovidien LPMRASA00022026-01-09
20810068810893Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAURIS HEALTH, INC.MON-000006-RFB2025-08-04
20810068811166Monarch Platform, Bronchoscopy 4.1, RefurbishedAURIS HEALTH, INC.MON-000008-RFB2025-08-04
05056139244933Apollo KneeCORIN LTDTKR.BB.14022025-04-07
05056139244940Apollo KneeCORIN LTDTKR.BB.14032025-04-07
05056139244971Apollo KneeCORIN LTDTKR.IN.16002025-04-07
05056139244988Apollo KneeCORIN LTDTKR.IN.17002025-04-07
05056139244995Apollo KneeCORIN LTDTKR.BB.17002025-04-07
05056139245008Apollo KneeCORIN LTDTKR.BB.17012025-04-07
05056139245015Apollo KneeCORIN LTDTKR.BB.17022025-04-07
05056139245022Apollo KneeCORIN LTDTKR.BB.17032025-04-07
05056139245039Apollo KneeCORIN LTDTKR.BB.17042025-04-07
05056139245053Apollo KneeCORIN LTDTKR.BB.17052025-04-07
05056139245060Apollo KneeCORIN LTDTKR.BB.17062025-04-07
05056139245077Apollo KneeCORIN LTDTKR.BB.17072025-04-07
05056139245145Apollo KneeCORIN LTDTKR.IN.18002025-04-07
05056139245176Apollo KneeCORIN LTDTKR.BB.15002025-04-07
05056139245718Apollo KneeCORIN LTDTKR.IN.14002025-04-07
05056139245770Apollo KneeCORIN LTDTKR.BB.11002025-04-07
05056139245787Apollo KneeCORIN LTDTKR.BB.11012025-04-07
05056139245794Apollo KneeCORIN LTDTKR.BB.11022025-04-07
05056139245800Apollo KneeCORIN LTDTKR.BB.11032025-04-07
05056139245817Apollo KneeCORIN LTDTKR.BB.12002025-04-07
05056139246715Apollo KneeCORIN LTDTKR.IN.18502025-04-07
05056139246722Apollo KneeCORIN LTDTKR.IN.13412025-04-07
05056139246739Apollo KneeCORIN LTDTKR.IN.13422025-04-07
05056139246746Apollo KneeCORIN LTDTKR.IN.13312025-04-07
05056139246753Apollo KneeCORIN LTDTKR.IN.13322025-04-07
05056139246760Apollo KneeCORIN LTDTKR.IN.13512025-04-07
05056139246777Apollo KneeCORIN LTDTKR.IN.13522025-04-07
05056139249518Apollo KneeCORIN LTDTKR.OB.19002025-04-07
05056139250651Apollo KneeCORIN LTDTKR.OB.11502025-04-07
20810068810985Monarch Platform, Bronchoscopy 4.1AURIS HEALTH, INC.MON-0000082025-03-03
00815440022266SenhanceAsensus Surgical, Inc.X90077702025-01-14
00815440022273SenhanceAsensus Surgical, Inc.X90077712025-01-14
05056139244926Apollo KneeCORIN LTDTKR.BB.14012025-01-10
05056139245756Apollo KneeCORIN LTDTKR.OB.10002024-12-17
05056139245763Apollo KneeCORIN LTDTKR.OB.11002024-12-17
05056139245824Apollo KneeCORIN LTDTKR.BB.10002024-12-17
05056139245831Apollo KneeCORIN LTDCOR.ST.00012024-12-17
05056139245862Apollo KneeCORIN LTDTKR.SS.00012024-12-17
05056139246005Apollo KneeCORIN LTDCOR.ST.00112024-12-17
05056139246012Apollo KneeCORIN LTDCOR.TS.00052024-12-17
05056139246029Apollo KneeCORIN LTDCOR.TS.00152024-12-17
05056139246036Apollo KneeCORIN LTDCOR.ST.01002024-12-17
05056139246784Apollo KneeCORIN LTDTKR.OB.13502024-12-17
05056139246791Apollo KneeCORIN LTDTKR.BB.14502024-12-17
07640184840141Dexter L6 Accessory trayDistalmotion SADexter L62024-11-24
07640184840158Dexter L6 Handle GripDistalmotion SADexter L62024-11-24
07640184840189Dexter L6 Incision PointerDistalmotion SADexter L62024-11-24
07640184840226Dexter L6 Endoscope CartDistalmotion SADexter L62024-11-24
07640184840240Dexter Sterile InterfaceDistalmotion SADexter L62024-11-24
07640184840400Dexter L6 Emergency Release ToolDistalmotion SADexter L62024-11-24
07640184840424Dexter Bipolar Maryland DissectorDistalmotion SADexter L62024-11-24
07640184840448Dexter Bipolar Johann GrasperDistalmotion SADexter L62024-11-24
07640184840462Dexter Needle HolderDistalmotion SADexter L62024-11-24
07640184840486Dexter Monopolar ScissorsDistalmotion SADexter L62024-11-24
07640184840509Dexter Monopolar HookDistalmotion SA Dexter L62024-11-24
07640184840516Dexter L6 RobotDistalmotion SADexter L62024-11-24
00810060831632ARTAS iX Venus Concept Inc.System2018-11-12
00850038042004MIRAVirtual Incision Corporation180-000000-0002024-06-24
00850038042028MIRAVirtual Incision Corporation180-020000-0002024-06-24
00850038042042MIRAVirtual Incision Corporation180-040000-0002024-06-24
10810068810803Monarch Bronchscope 2.0/Monarch Platform (P2)Auris Health, Inc.MON-0000062024-05-05
00885556917435Real IntelligenceSmith & Nephew, Inc.ROB200402024-04-10
00886874119662daVinci 5INTUITIVE SURGICAL, INC.3807462024-03-21
00886874119716daVinci 5INTUITIVE SURGICAL, INC.3807472024-03-21
00886874119747daVinci 5INTUITIVE SURGICAL, INC.3807302024-03-21