55 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BTL-084
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994399984·PLATE 6190023 23MM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690196471·EVO Stylus 2mm / 10mm
Q-Rejuvalight Pro Facewear
FDA UDI
Light Tree Ventures Europe B.V.·08719327598719·
Q-Rejuvalight Pro Facewear (Model: P19-0023)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
FDA 510(k)
FDA Class 2
·Neurology
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Portico Transcatheter Aortic Valve Implantation System
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 18, 2025
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Portico Transcatheter Aortic Heart Valve
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Navitor Transcatheter Aortic Heart Valve, Portico Transcatheter Aortic Heart Valve, FlexNav Delivery System
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Navitor TAVI System with Vision Technology
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Navitor Transcatheter Aortic Valve Implantation System