23 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Taiwan
×
ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED
Device
EU MDD
·
Eu Md Class 2a
·Omnimate Enterprise Co., Ltd.·On the market·1 country
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDD
·
Eu Md Class 1
·Bionime Corporation·On the market·1 country
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDD
·
Eu Md Class 1
·Bionime Corporation·On the market·3 countries
RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·Foremount Enterprise Co., Ltd.·On the market
RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·Foremount Enterprise Co., Ltd.·On the market
RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·Foremount Enterprise Co., Ltd.·On the market
RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·Foremount Enterprise Co., Ltd.·On the market
RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·Foremount Enterprise Co., Ltd.·Not intended for eu market
RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·Foremount Enterprise Co., Ltd.·Not intended for eu market
RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·Hsiner Co., Ltd.·On the market
RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·Hsiner Co., Ltd.·On the market
RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·Hsiner Co., Ltd.·On the market
RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·Hsiner Co., Ltd.·On the market
RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·Hsiner Co., Ltd.·On the market
MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS)
Device
EU MDR
·
Eu Md Class 1
·MAKRITE INDUSTRIES INC.·On the market
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
FDA Enforcement
Class II
·Ongoing·Flux Technology Inc.·June 11, 2025
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
Gas Sampling Line W/Filter (Male/Female), 7ft
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Besmed Health Business Corp.·1 device
Gas Sampling Line W/Filter (Male/ Male), 7ft
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Besmed Health Business Corp.·1 device