560 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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
TC MAYO-HEGAR NDL HOLDERHVYSERR185MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code HXK·August 13, 2015
PILLING CASTROVIEJO NH 7"
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code HXK·April 9, 2010
PILLING CASTROVIEJO NH 8"
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code HXK·April 9, 2010
CLASSIC PLUS(R) STERNAL NEEDLE HOLDER
FDA Adverse Event
SYMMETRY SURGICAL INC.·Product code HXK·September 15, 2015
TC DE'BAKEY NEEDLE HOLDERDELSERR165MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code HXK·October 15, 2014
TC DE'BAKEY NDL HOLDER DEL SERR 260MM
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code HXK·April 12, 2021
TC MAYO-HEGAR NDL HOLDERHVYSERR205MM
FDA Adverse Event
Injury
·AESCULAP AG·Product code HXK·November 2, 2021
V. MULLER
FDA Adverse Event
Malfunction
·CAREFUSION·Product code HXK·March 13, 2012
TC MAYO-HEGAR NDL HOLDERHVYSERR205MM
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code HXK·August 21, 2015
CLASSIC PLUS® NEEDLE HOLDER, CRILE-WOOD, 6 IN.
FDA Adverse Event
Malfunction
·SYMMETRY SURGICAL INC.·Product code HXK·October 21, 2025
DUROGRIP NEEDLE HOLDER STR.D:5/310MM
FDA Adverse Event
Injury
·AESCULAP AG·Product code HXK·December 20, 2018
CODMAN CLASSIC PLUS NEEDLE HOLDER
FDA Adverse Event
Malfunction
·SYMMETRY SURGICAL FORMERLY CODMAN & SPECIALTY SURGICAL INSTRUMENTATION·Product code HXK·April 1, 2013
TC BABY-CRILE-WOOD NDL HLDR SERR 150MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code HXK·June 25, 2013
SYMMETRY
FDA Adverse Event
Malfunction
·SYMMETRY SURGICAL INC·Product code HXK·September 20, 2023
SYMMETRY
FDA Adverse Event
Malfunction
·SYMMETRY SURGICAL INC·Product code HXK·September 20, 2023
TC HALSEY NEEDLE HOLDER SERR 130MM
FDA Adverse Event
Injury
·AESCULAP AG·Product code HXK·September 25, 2023
SHARPSHOOTER HANDLE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code HXK·July 17, 2023
TC BABY-CRILE-WOOD NDL HLDR SERR 150MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code HXK·June 25, 2013