891 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024
Total Knee Junior Model Number 1100 Product Usage: The Total Knee Junior is an external polycentric prosthetic knee with a geometric locking system.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISY·August 10, 2009
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
Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ITQ·February 24, 2016
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·December 26, 2023
LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapter 153 165mm (6 - 6 1/2) -Male pyramid adapter -Female pyramid adapter -Maintenance free, no lubrication required -Maximum weight: 147kg (325lbs) -Available in sizes 22-30
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISH·March 4, 2015
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
Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code KQZ·March 14, 2016
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
FDA Recall
Open, Classified
·PHASE SCIENTIFIC INTERNATIONAL LIMITED 1/f, E Phase 3 Hong Kong Science Park Sha Tin Hong Kong SAR·Product code QMN·October 25, 2023