21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IVYLASER Handhold Hair Removal Machine
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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...
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·Xstim Spine Fusion Stimulator
SONENDO ENDOTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·Xstim Spine Fusion Stimulator
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
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
XPANDER II IBT
FDA Adverse Event
Malfunction
·KYPHON NEUCHATEL·Product code HRX·July 16, 2013
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 19, 2022