12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·July 31, 2019
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
FDA Enforcement
Class II
·Completed·Vyaire Medical·June 21, 2023
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
FDA Enforcement
Class II
·Completed·Vyaire Medical·June 21, 2023
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
FDA Recall
Completed
·Invivo Corporation·Product code DQK·September 24, 2018
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.
FDA Recall
Completed
·Bard Peripheral Vascular Inc·Product code LJT·June 25, 2018
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
FDA Recall
Completed
·Philips Ultrasound, Inc.·Product code IYN·October 9, 2023
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
FDA Recall
Completed
·Trumpf Medical Systems, Inc.·Product code FSY·November 2, 2015
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
FDA Recall
Completed
·Philips Ultrasound, Inc.·Product code IYN·October 9, 2023
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
FDA Recall
Completed
·Vyaire Medical·Product code CBK·May 5, 2023
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
FDA Recall
Completed
·Vyaire Medical·Product code CBK·May 5, 2023
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).
FDA Enforcement
Class II
·Completed·Mako Surgical Corporation·November 25, 2020
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).
FDA Recall
Completed
·Mako Surgical Corporation·Product code OLO·October 23, 2020