131 results
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26ms
·
Sources: EU EUDAMED, US FDA
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·Xstim Spine Fusion Stimulator
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·Xstim Spine Fusion Stimulator
LessRay
FDA UDI
Nuvasive, Inc.·00887517814135·LessRay BNC Cable, 25 ft.
LEONE SPA
FDA UDI
LEONE SPA·08033707022848·CALIBRA BANDS 2ND MOLAR n.SUL 25
QuPID® Plus hCG Pregnancy Test
FDA UDI
STANBIO LABORATORY, L.P.·00657498001318·For the qualitative determination of human chor...
PCRopsis
FDA UDI
ENTOPSIS, LLC·B55012300250·PCRopsis™ Reagent 123 (25 mL) mediates extracti...
IVYLASER Handhold Hair Removal Machine
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069520217·Widex D-CIC (Light beige ) Dream 330, Left, RC ...
Widex
FDA UDI
Widex A/S·05706069887105·WIDEX MOMENT M-IP (Light beige ) 330, Right
Widex
FDA UDI
Widex A/S·05706069888973·WIDEX MOMENT M-CIC (Light beige ) 330, Left
Widex
FDA UDI
Widex A/S·05706069560183·Widex UNIQUE U-CIC (Light beige ) 330, Left, RC...
Widex
FDA UDI
Widex A/S·05706069673326·Widex EVOKE E-CIC (Light beige ) 330, Left, RC ...
Widex
FDA UDI
Widex A/S·05706069655070·Widex UNIQUE U-IP (Light beige ) 330, Right
Widex
FDA UDI
Widex A/S·05706069686838·Widex EVOKE E-IP (Light beige ) 330, Right
ALTIUS SYSTEM
FDA Adverse Event
Malfunction
·NEUROS MEDICAL INC.·Product code LGW·April 2, 2025
ALTIUS SYSTEM
FDA Adverse Event
Malfunction
·NEUROS MEDICAL INC.·Product code LGW·June 20, 2025
Cross-Sectional Mammographic Xray System
FDA Pre-Market Approval
FDA Class 3
·KONING BREAST CT (MODEL CBCT1000)
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
PULSE GEN MODEL 104
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·November 12, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 31, 2011