10,000 results
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52ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Kit, Screening, Yeast
FDA classification
FDA Class 1
·Kit, Screening, Yeast
JBC CORP
FDA registration
JBC CORP·5 products·🇺🇸 United States
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
FDA Enforcement
Class II
·Terminated·Karl Storz Endoscopy·April 8, 2020
JBC AND COMPANY
FDA registration
JBC AND COMPANY·1 product·🇺🇸 United States
JBC TECHNOLOGIES, INC.
FDA registration
JBC TECHNOLOGIES, INC.·1 product·🇺🇸 United States
JAC CUSTOM POUCHES
FDA registration
JAC CUSTOM POUCHES·4 products·🇺🇸 United States
JAC-CELL MEDIC
FDA registration
JAC-CELL MEDIC·1 product·🇨🇦 Canada
JBC TECHNOLOGIES, INC.
FDA registration
JBC TECHNOLOGIES, INC.·1 product·🇺🇸 United States
2XC MICROSCOPE
FDA 510(k)
FDA Class 1
·Pathology
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code EQN·December 6, 2019
SURGIFORM
FDA UDI
SURGICAL TECHNOLOGY LABORATORIES INC·00851988007228·DCC-3XC Deep Concave Chin Silicone Implants
SURGIFORM
FDA UDI
SURGICAL TECHNOLOGY LABORATORIES INC·00851988007204·DCC-1XC Deep Concave Chin Silicone Implants
Swede Dental
FDA UDI
AMERICAN EAGLE INSTRUMENTS, INC.·00841013117657·GRACEY ACCESS 1-2 (3/8) PURPLE
SURGIFORM
FDA UDI
SURGICAL TECHNOLOGY LABORATORIES INC·00851988007211·DCC-2XC Deep Concave Chin Silicone Implants
JOC GREAT WALL CORP
FDA registration
JOC GREAT WALL CORP·1 product·🇨🇳 China
STARDENTAL AXCS STERILE WATER SYSTEM
FDA 510(k)
FDA Class 1
·Dental
SLZ 3XC REF
FDA UDI
KEELER LIMITED·05055272715416·
SLZ 5XC REF
FDA UDI
KEELER LIMITED·05055272715508·
SLZ 5XC TBL
FDA UDI
KEELER LIMITED·05055272715515·
SLZ 3XC TBL
FDA UDI
KEELER LIMITED·05055272715423·