21 results
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51ms
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Sources: EU EUDAMED, US FDA
Conavi Medical Inc
FDA registration
Conavi Medical Inc·5 products·🇨🇦 Canada
Novasight Hybrid™ PIM
FDA UDI
Conavi Medical Inc·00628055603092·Imaging System
Novasight Hybrid™ Catheter
FDA UDI
Conavi Medical Inc·00628055603115·Imaging catheter consists of Novasight Hybrid C...
Novasight Hybrid™ Catheter Accessories Package
FDA UDI
Conavi Medical Inc·00628055603061·Imaging catheter accessories
Novasight Hybrid™ Catheter PIM Bag
FDA UDI
Conavi Medical Inc·00628055603108·Imaging catheter accessories
Novasight Hybrid™ Catheter
FDA UDI
Conavi Medical Inc·00628055603054·Imaging catheter
Novasight Hybrid™ Hummingbird Console
FDA UDI
Conavi Medical Inc·00628055603078·Imaging System
Foresight ICE™ Hummingbird Console
FDA UDI
Conavi Medical Inc·00628055603030·Imaging system
Novasight Hybrid™ PIM
FDA UDI
Conavi Medical Inc·00628055603085·Imaging System
Foresight ICE™ Catheter
FDA UDI
Conavi Medical Inc·00628055603016·Imaging catheter
Foresight ICE™ Catheter Accessories Package
FDA UDI
Conavi Medical Inc·00628055603023·Imaging catheter accessories
Foresight ICE™ PIM
FDA UDI
Conavi Medical Inc·00628055603047·Imaging system
NOVASIGHT HYBRID SYSTEM
FDA Adverse Event
Malfunction
·CONAVI MEDICAL INC.·Product code OBJ·December 20, 2024
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
FDA Recall
Open, Classified
·Conavi Medical Inc.·Product code OBJ·March 12, 2025
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
FDA Enforcement
Class I
·Ongoing·Conavi Medical Inc.·April 30, 2025
O-ARM 1000 IMAGING SYSTEM 3RD EDITION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·August 2, 2016
NAVISTAR® THERMOCOOL®
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·December 1, 2014
NAVISTAR® THERMOCOOL®
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·December 2, 2014
NAVISTAR® THERMOCOOL®
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·December 2, 2014
NAVISTAR® THERMOCOOL®
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·December 1, 2014