8 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BN LUMBAR CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017774·K-Wire, Double Ended, Trocar Point, Diameter Si...
CALYPSO SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 31, 2013
NONE
FDA Adverse Event
Malfunction
·INVACARE·Product code ITJ·June 16, 2011
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIO·August 28, 2008
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
FDA Enforcement
Class II
·Ongoing·Intuitive Surgical, Inc.·June 10, 2026