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Device Explorer · FDA GUDID · GMDN 38678

Robotic surgical telemanipulation system

An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a complete functional extension of the surgeon (master-stave telemanipulation) for precise bone and soft-tissue modelling or soft-tissue removal (e.g., durin

US‑registered devices225in commercial distribution
Companies20labelers on GUDID
Single‑use12%of device records
Sterile7%labelled sterile
Prescription78%Rx‑only share
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Share of device records

Corin Ltd4118%
Smith & Nephew, Inc.3214%
Medrobotics Corporation3013%
Intuitive Surgical, Inc.2411%
Globus Medical, Inc.2411%
Distalmotion Sa188%
Auris Health, Inc.157%
Covidien Lp63%

Top labelers

CompanyDevicesShare
Corin Ltd4118%
Smith & Nephew, Inc.3214%
Medrobotics Corporation3013%
Intuitive Surgical, Inc.2411%
Globus Medical, Inc.2411%
Distalmotion Sa188%
Auris Health, Inc.157%
Covidien Lp63%
Medical Microinstruments, Inc.63%
Orthosoft Inc42%
Restoration Robotics, Inc.42%
Think Surgical, Inc.42%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ACEXACT ACE RobotVersius Visualisation Bedside UnitVersius Instrument Bedside UnitVersius Surgeon ConsoleApollo KneeOp.n™ CoBotCoBotCLINICAL PCROSA® KNEE OPTICAL UNITROSA® ReconROSA® Recon PlatformdaVinci 5daVinci XidaVinci Xda Vinci Xi

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OLOOrthopedic stereotaxic instrument84
NAYSystem, Surgical, Computer Controlled Instrument51
OLOOrthopedic Stereotaxic Instrument48
NAYSystem,Surgical,Computer Controlled Instrument35
HAWNeurological stereotaxic Instrument24
EOBNasopharyngoscope (Flexible Or Rigid)20

GMDN & GCC registration

  • GMDN code 38678 · non‑implantable
  • Single‑use 12% · sterile 7% · Rx‑only 78% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 2Width (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many robotic surgical telemanipulation system products are registered in the US?

225 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Robotic surgical telemanipulation system", from 20 companies. The largest labeler is Corin Ltd with 18% of records.

Which FDA product codes apply?

OLO (Orthopedic stereotaxic instrument), NAY (System, Surgical, Computer Controlled Instrument), OLO (Orthopedic Stereotaxic Instrument), NAY (System,Surgical,Computer Controlled Instrument)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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