10,000 results
·
53ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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
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
UNK DEPUY ANKLE SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KXC·June 16, 2009
UNKNOWN ANKLE TIBIAL INSERT
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KXC·November 5, 2020
UNK
FDA Adverse Event
Injury
·UNK·Product code KXC·March 20, 1997
BUECHEL-PAPPAS TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·ENDOTEC INC.·Product code KXC·May 19, 2008
Prosthesis, Ankle, Cemented, Non-Constrained
FDA classification
FDA Class 3
·Prosthesis, Ankle, Cemented, Non-Constrained
2XC MICROSCOPE
FDA 510(k)
FDA Class 1
·Pathology
KLC SERVICES, INC./REEP
FDA registration
KLC SERVICES, INC./REEP·1 product·🇺🇸 United States
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
Medline Industries, LP - Mexicali (MXC)
FDA registration
Medline Industries, LP - Mexicali (MXC)·198 products·🇲🇽 Mexico
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·
HS-FIBER
FDA UDI
RIVERPOINT MEDICAL, LLC·00812444023978·SUTURE