46 results
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26ms
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Sources: EU EUDAMED, US FDA
XOD Inc
FDA registration
XOD Inc·3 products·🇺🇸 United States
XOD Breeze dermabrasion brush
FDA UDI
XOD Inc.·G650BREEZE1·
XOD DioGo compact diode laser
FDA UDI
XOD Inc.·G650DIOGO1·
Wonder Touch
FDA UDI
XOD Inc.·D650WONDER1·
Associates of Cape Cod, Inc
Manufacturer
🇺🇸 United States·1 Importer
RODIN Cement
FDA 510(k)
FDA Class 2
·Dental
VOXAPOD
FDA UDI
Voxa Pod, Inc.·00860000762373·menstrual cup medical-grade silicone
VOXAPOD
FDA UDI
Voxa Pod, Inc.·00860000762311·menstrual cup small/medium gray
VOXAPOD
FDA UDI
Voxa Pod, Inc.·00860000762335·VOXAPOD menstrual cup small is a uniquely desig...
VOXAPOD
FDA UDI
Voxa Pod, Inc.·00860000762397·menstrual cup
VOXAPOD
FDA UDI
Voxa Pod, Inc.·00860000762342·
VOXAPOD
FDA UDI
Voxa Pod, Inc.·00860000762380·medical-grade silicone menstrual cup
ASSOCIATES OF CAPE COD, INC.
FDA registration
ASSOCIATES OF CAPE COD, INC.·3 products·🇺🇸 United States
BG Analytics Software
FDA UDI
ASSOCIATES OF CAPE COD, INC.·00862696000289·a calculator/data processing module for clinica...
Fungitell STAT
FDA UDI
ASSOCIATES OF CAPE COD, INC.·00862696000227·
THE PRO-TRAC II TACROLIMUS ELISA KIT
FDA Adverse Event
Malfunction
·DIASORIN, INC.·Product code MLM·March 16, 2015
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·August 29, 2019
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·August 10, 2016
MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·August 10, 2016
Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·August 10, 2016