15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Scarlet AL-T
FDA 510(k)
FDA Class 2
·Orthopedic
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704512939·
DynaClip
FDA UDI
Medshape, Inc.·M9703000001818180·DYNACLIP STAPLE, 18X18X18MM
BIOLOK MICRO-LOK IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
4CIS VANE SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JAWS Nitinol Staple System
FDA UDI
Paragon 28, Inc.·00889795040312·Straight Staple Assembly, 18 x 18mm
JAWS® Nitinol Staple System
FDA UDI
Paragon 28, Inc.·00889795124210·JAWs Great White Nitinol Staple System, 18 x 18...
DynaBridge
FDA UDI
FUSION ORTHOPEDICS, LLC·00819034027972·Superelastic Nitinol Implant Style B 18mm x 18m...
DynaBridge
FDA UDI
FUSION ORTHOPEDICS, LLC·00819034023417·Superelastic Nitinol Implant Style B 18 x 18 x ...
eXpress®
FDA UDI
NOVASTEP·03700879502342·Compressive staple 18-18-18
DynaBridge
FDA UDI
FUSION ORTHOPEDICS, LLC·00819034023547·Superelastic Nitinol Implant System Style B 18 ...
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 21, 2013
COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)
FDA Adverse Event
Injury
·ETHICON·Product code GAM·July 28, 2011
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