34 results
·
39ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·July 3, 2024
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·November 27, 2024
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·November 27, 2024
Acrobat-i Positioner. Model Number C-XP-5000Z
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·November 27, 2024
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
FDA Enforcement
Class I
·Ongoing·Maquet Cardiovascular, LLC·November 6, 2024
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·July 17, 2024
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·July 17, 2024
The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·July 3, 2024
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·April 12, 2023
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·April 12, 2023
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·April 13, 2022
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·April 12, 2023
Vasoshield Syringe Packs, Model VH-5001
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·January 25, 2023
Hemopro 2 with Vasoshield, Model VH-4001
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·January 25, 2023
Fusion Bioline Vascular Graft, Part number M00201503046B0
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·March 22, 2023
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·November 1, 2023
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
FDA Enforcement
Class I
·Ongoing·Maquet Cardiovascular, LLC·January 24, 2024
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·January 24, 2024
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023