21 results · 21ms · Sources: EU EUDAMED, 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