145 results
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37ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ITW·February 24, 2016
Ossur Lil Angel Vest P2 Kodel. 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
Ossur Lil Angel Vest P2 Sorbatex. 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
RKNXC0005, RHEO KNEE XC 5 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
Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IPY·February 24, 2016
RKN130002, RHEO KNEE 2 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
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISH·May 12, 2023
Ossur Lil Angel Vest P3 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
NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·February 24, 2016
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·August 20, 2024
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·February 26, 2015
Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·February 24, 2016
Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper anatomical airway and spinal alignment. The occipital shape protects against positional plagiocephaly.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·February 24, 2016
Ossur Lil Angel Vest P3 Sorbatex. 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
Ossur Lil Angel Vest P3 Kodel. 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
Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ITW·February 24, 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