55 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEWDEAL ANKLE NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tray. The product is available in six (6) sizes. All nails are color-coded for easy size identification. Bony fixation is achieved using two (2) tibial screws, two (2) calcaneal screws and one (optional) talar screw. The nail, cross-locking screws and end cap are manufactured from a titanium alloy: TI-6AI-4V ELI ISO 5832-3, ASTM F136. The PANTA Arthrodesis Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. The Panta Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: " Post-traumatic and degenerative arthritis involving both ankle and subtalar joints. " Rheumatoid arthritis. " Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body. " Revision of failed total ankle arthroplasty with subtalar intrusion. " Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis). " Avascular necrosis of the talus. " Neuroarthropathy or neuropathic ankle deformity. " Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease. " Severe pilon fractures with trauma to the subtalar joint.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSB·May 19, 2011
CENTERPIECE PLATE FIXATION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NQW·August 10, 2017
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BLUE SKY BIO DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CENTERPIECE? PLATE FIXATION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code NQW·April 16, 2015
CENTERPIECE¿ PLATE FIXATION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NQW·June 8, 2016
CENTERPIECE PLATE FIXATION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NQW·December 7, 2017
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026
CENTERPIECE PLATE FIXATION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NQW·July 28, 2019
CENTERPIECE PLATE FIXATION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NQW·July 28, 2019
CENTERPIECE PLATE FIXATION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NQW·May 22, 2019
CENTERPIECE PLATE FIXATION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NQW·May 22, 2019
CENTERPIECE PLATE FIXATION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NQW·June 11, 2020
CENTERPIECE PLATE FIXATION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NQW·March 1, 2018
CENTERPIECE PLATE FIXATION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NQW·February 22, 2018
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 10, 2013
PROMOTE RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 1, 2011
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·May 22, 2009