10,000 results
·
66ms
·
Sources: EU EUDAMED, US FDA
RHEO KNEE
FDA Adverse Event
Injury
·OSSUR H/F·Product code ISW·February 22, 2010
SYMBIONIC KNEE
FDA Adverse Event
Injury
·OSSUR H/F·Product code ISW·October 25, 2017
RHEO KNEE 3 WP
FDA Adverse Event
Injury
·OSSUR H/F·Product code ISW·December 13, 2017
ICEROSS DERMO SEAL-IN LINER
FDA Adverse Event
Injury
·OSSUR H/F·Product code ISS·March 15, 2007
SYMBIONIC LEG 3
FDA Adverse Event
Malfunction
·OSSUR H/F·Product code ISW·October 17, 2018
RHEO KNEE
FDA Adverse Event
Injury
·OSSUR H/F·Product code ISW·December 27, 2006
ICELOCK CLUTCH
FDA Adverse Event
Other
·OSSUR H/F·Product code ISS·August 14, 2009
ALIGNMENT CUP WITH FEMALE PYRAMID
FDA Adverse Event
Other
·OSSUR H/F·Product code ISS·August 13, 2008
ICELOCK CLUTCH 211
FDA Adverse Event
Injury
·OSSUR H/F·Product code ISS·July 29, 2008
RHEO KNEE 3 W/LOCK
FDA Adverse Event
Injury
·OSSUR H/F·Product code ISW·August 3, 2017
ICELOCK CLUTCH
FDA Adverse Event
Injury
·OSSUR H/F·Product code ISS·September 13, 2006
TALUX PYRAMID C6 27CM RIGHT
FDA Adverse Event
Injury
·OSSUR H/F·Product code ISH·April 20, 2017
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
FDA Enforcement
Class II
·Ongoing·Ossur H / F·October 9, 2024
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Enforcement
Class II
·Ongoing·Ossur H / F·May 22, 2024
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Enforcement
Class II
·Ongoing·Ossur H / F·May 22, 2024
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Enforcement
Class II
·Ongoing·Ossur H / F·May 22, 2024
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Enforcement
Class II
·Ongoing·Ossur H / F·May 22, 2024
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 Enforcement
Class II
·Terminated·Ossur H / F·April 6, 2016
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 Enforcement
Class II
·Terminated·Ossur H / F·March 25, 2015
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 Enforcement
Class II
·Terminated·Ossur H / F·April 6, 2016