7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LANCER SPECIMEN CONTAINER
FDA 510(k)
FDA Class 1
·Pathology
CAD 12, COLONOSCOPY ASSIST DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cartiva SCI instrumentation set
FDA 510(k)
FDA Class 2
·Orthopedic
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 11, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 8, 2014
TAG 3.7MM ROD II
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURING·Product code MBI·August 10, 2010
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
FDA Enforcement
Class II
·Ongoing·Intuitive Surgical, Inc.·February 11, 2026