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Sources: EU EUDAMED, US FDA
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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
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
K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.
FDA Recall
Terminated
·Breg Inc·Product code IQI·March 14, 2014
Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQI·February 24, 2016
PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code IQI·November 7, 2016
Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
FDA Recall
Terminated
·United Surgical Associates·Product code IQI·April 13, 2015
TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code IQI·November 7, 2016
Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in motocross activities.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQI·February 24, 2016
Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQI·February 24, 2016
Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQI·February 24, 2016
FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
FDA Recall
Terminated
·3M Company Health Care Business 3m Center·Product code IQI·January 31, 2018
Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQI·February 24, 2016
ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
FDA Recall
Terminated
·3M Company Health Care Business 3m Center·Product code IQI·January 31, 2018
Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQI·February 24, 2016
Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQI·February 24, 2016
Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
FDA Recall
Terminated
·Breg Inc·Product code IQI·March 14, 2014
Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
FDA Recall
Terminated
·Irvine Biomedical Inc, a St. Jude Medical Co.·Product code DRF·August 24, 2020
Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
FDA Recall
Terminated
·Irvine Biomedical Inc, a St. Jude Medical Co.·Product code DRF·August 24, 2020
RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·December 31, 2014
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·May 22, 2013