590 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
FDA Enforcement
Class II
·Terminated·Clinical Innovations, LLC·October 21, 2015
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
FDA Recall
Terminated
·Clinical Innovations, LLC·Product code OQY·January 5, 2015
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
FDA Recall
Terminated
·Clinical Innovations, LLC·Product code OQY·December 30, 2014
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
FDA Enforcement
Class II
·Terminated·Butterfly Network, Inc.·April 8, 2020
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics·September 26, 2018
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
FDA Recall
Terminated
·Butterfly Network, Inc.·Product code IYN·February 24, 2020
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
FDA Recall
Terminated
·Mizuho OSI·Product code JEA·December 17, 2012
216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.
FDA Recall
Terminated
·Mizuho OSI·Product code FWZ·March 28, 2017
Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.
FDA Recall
Terminated
·Mizuho OSI·Product code GDC·December 14, 2015
Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.
FDA Recall
Terminated
·Mizuho OSI·Product code JEA·October 14, 2019
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
FDA Enforcement
Class II
·Terminated·Mizuho OSI·February 20, 2013
Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.
FDA Enforcement
Class II
·Terminated·Mizuho OSI·February 17, 2016
216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.
FDA Enforcement
Class II
·Terminated·Mizuho OSI·April 26, 2017
Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.
FDA Enforcement
Class II
·Terminated·Mizuho OSI·October 21, 2020
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CGZ·July 11, 2018
VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
FDA Recall
Terminated
·Cordis Corporation·Product code DQY·December 7, 2004
Arrow Multi-Lumen CVC w/ BlueFlex Tip (Central Venous Catheter)
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·February 11, 2009
AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature.
FDA Recall
Terminated
·AGA Medical Corporation·Product code DQY·December 18, 2009
Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
FDA Recall
Terminated
·Spectranetics Corporation·Product code DQY·July 18, 2011
NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code DQY·January 11, 2013