FDA.reportPublic FDA data

Robotic surgical system

Definition
An assembly of electromechanical devices typically used during orthopaedic 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, e.g., an operator console and 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
217
Last updated
2023-06-16 08:27:24

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810060830079ARTAS SystemVenus Concept Inc.FP-250002023-06-08
03701311500322CoBotECENTIAL ROBOTICSI000192023-03-01
07290017702254ACEXACT ROBOTICS LTDD2022-07-20
00815440022280SenhanceAsensus Surgical, Inc.X90077752022-07-11
00885556806548RI Hip Navigation CoriSmith & Nephew, Inc.ROB200182022-04-15
00885556806609RI Hip NavigationSmith & Nephew, Inc.ROB200242022-04-15
00885556775547Real IntelligenceSmith & Nephew, Inc.ROB104002022-01-10
00193982143473EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.25042021-09-23
00193982185220EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.25052021-09-23
00193982192358EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.18262021-09-23
00193982192365EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.18272021-09-23
00193982192518EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.16982021-09-23
00193982192532EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.17032021-09-23
00193982192549EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.17042021-09-23
00193982192556EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.17122021-09-23
00193982192563EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.17432021-09-23
00193982192570EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.17802021-09-23
00193982192587EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.19202021-09-23
00193982192594EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.19212021-09-23
00193982192600EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.19222021-09-23
00193982192617EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.19232021-09-23
00193982192624EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.19252021-09-23
00193982192631EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.19302021-09-23
00193982192648EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.19312021-09-23
00193982192655EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.19322021-09-23
00193982192662EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.19332021-09-23
00193982192679EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.19342021-09-23
00193982192686EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.19382021-09-23
00193982302238EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.1834S2021-09-23
00193982302269EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.1842S2021-09-23
00193982302320EXCELSIUS GPSGLOBUS MEDICAL, INC.6143.1870S2021-09-23
B634MON0007091Monarch Advanced Imaging Accessory KitAURIS HEALTH, INC.MON-0007092021-07-15
00886874114605da Vinci SPINTUITIVE SURGICAL, INC.3806012020-09-08
00885556773673Real IntelligenceSmith & Nephew, Inc.ROB200002020-08-27
00815440021931Senhance TRANSENTERIX, INC.X9007696 2020-08-05
00815440022075SenhanceTRANSENTERIX, INC.X90077082020-08-05
00815440022082Senhance TRANSENTERIX, INC.X90077072020-08-05
B634MON000005010 Monarch Endoscopy Platform (P1) Tower UpgradeAURIS HEALTH, INC.MON-000005-012020-07-13
B634MON00000501 Monarch Endoscopy Platform (P1) Tower UpgradeAURIS HEALTH, INC.MON-000005-012020-03-25
B634MON0000060Monarch Bronchscope 2.0/Monarch Platform (P2)AURIS HEALTH, INC.MON-0000062020-04-21
00850190004018FLEXMEDROBOTICS CORPORATION229952019-10-30
00850190004025FLEXMEDROBOTICS CORPORATION246982019-10-30
00850190004032FLEXMEDROBOTICS CORPORATION246992019-10-30
00850190004070FLEXMEDROBOTICS CORPORATION231572019-10-30
00850190004087FLEXMEDROBOTICS CORPORATION234982019-07-01
00850190004100FlexMEDROBOTICS CORPORATION251712019-07-01
00850190004124FlexMEDROBOTICS CORPORATION251732019-07-01
00850190004131FLEXMEDROBOTICS CORPORATION251782019-07-01
00850190004513FLEXMEDROBOTICS CORPORATION253272019-04-01
00850190004520FLEXMEDROBOTICS CORPORATION253282019-04-01
00850190004537FLEXMEDROBOTICS CORPORATION253292018-12-07
00850190004544FLEXMEDROBOTICS CORPORATION253302019-04-01
00850190004551FLEXMEDROBOTICS CORPORATION253312018-12-07
00850190004568FLEXMEDROBOTICS CORPORATION253322018-12-07
00850190004711FLEXMEDROBOTICS CORPORATION255972019-04-30
00850190004742FlexMEDROBOTICS CORPORATION257762019-04-01
00850190004759FlexMEDROBOTICS CORPORATION257772019-04-01
00850190004766FlexMEDROBOTICS CORPORATION257782019-04-01
00850190004827FLEXMEDROBOTICS CORPORATION261142018-12-07
00850190004834FLEXMEDROBOTICS CORPORATION264702019-04-01
00850190004841FLEXMEDROBOTICS CORPORATION264712019-04-01
00850190004858FLEXMEDROBOTICS CORPORATION264722019-04-01
00850190004865FLEXMEDROBOTICS CORPORATION264732019-04-01
00850190004919FLEXMEDROBOTICS CORPORATION251712019-07-01
00850190004926FLEXMEDROBOTICS CORPORATIONInstrument Assembly part2019-07-01
00850190004933FLEXMEDROBOTICS CORPORATIONInstrument Assembly part2019-07-18
00885556780855REAL INTELLIGENCESmith & Nephew, Inc.ROB10024S2020-05-01
00885556780862REAL INTELLIGENCESmith & Nephew, Inc.ROB10025S2020-05-01
00889024511026ROSA® KNEE PLATFORM US PL BOrthosoft Inc20-8020-100-012019-03-06
00889024511170ROSA® KNEE ROBOTIC UNIT US PL BOrthosoft Inc20-8020-110-012019-03-06
00889024511323ROSA® KNEE OPTICAL UNITOrthosoft Inc20-8020-120-012019-03-06
00889024511354CLINICAL PCOrthosoft Inc20-8020-050-012019-03-06
00815440021122Senhance UltrasonicTRANSENTERIX, INC.X90076182019-02-04
00815440021405SenhanceTRANSENTERIX, INC.X90070342019-08-01
00815440021443SenhanceTRANSENTERIX, INC.X90073062019-02-04
00815440021450SenhanceTRANSENTERIX, INC.X90073092019-02-04
00815440021740SenhanceTRANSENTERIX, INC.X90076492019-02-04
00815440021757SenhanceTRANSENTERIX, INC.X90076602019-02-04
00815440021764SenhanceTRANSENTERIX, INC.X90076612019-02-04
00885556755068CORISmith & Nephew, Inc.ROB100002020-04-10