6 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Slit Guedel Airway, ISO 9,90mm

Device
EU MDR · Eu Md Class 1 ·Foremount Enterprise Co., Ltd.·On the market

Slit Guedel Airway, ISO 10,100mm

Device
EU MDR · Eu Md Class 1 ·Foremount Enterprise Co., Ltd.·On the market

IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II

FDA 510(k)
FDA Class 2 ·Physical Medicine

SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)

FDA 510(k)
FDA Class 2 ·Neurology

U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.

FDA Enforcement
Class II ·Terminated·United Orthopedic Corporation·March 28, 2018

U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.

FDA Enforcement
Class II ·Terminated·United Orthopedic Corporation·March 28, 2018