560 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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