120 results
·
60ms
·
Sources: EU EUDAMED, US FDA
HI-LINE MEDICAL PHACOEMULSIFIER TIP
FDA 510(k)
FDA Class 2
·Ophthalmic
RETROBULBAR NEEDLE
FDA Adverse Event
Injury
·HI-LINE MEDICAL·Product code FMF·January 27, 1995
GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; GE626SU; HI-LINE XS DISP.DIAM.BURR X-CRS.III D4.5; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code GEY·March 28, 2017
CADD
FDA Adverse Event
Injury
·SMITH'S MEDICAL·Product code FPA·March 28, 2007
LEGACY 6400
FDA Adverse Event
Injury
·SMITH (SIMS DELTEC)·Product code FRN·March 23, 2004
MEDEX LARGE BORE - HI-FLO STOPCOCK
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code FMG·April 25, 2019
EASY-LOCK DISCONNECT CAP WITH POVIDONE-IODINE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE, LTD.·Product code KDJ·July 7, 2003
EASY-LOCK DISCONNECT CAP WITH PROVIDONE-IODINE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE, LTD.·Product code KDJ·July 7, 2003
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·January 25, 2012
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·August 4, 2012
HI-FLO(TM)4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FMG·August 31, 2023
RELION SK
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·February 13, 2017
RELION SK
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·April 20, 2018
NOVAMAX LINK GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORPORATION·Product code NBW·May 11, 2012
MICROCLAVE NEUTRAL DISPLACEMENT CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC·Product code FPA·February 11, 2011
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·November 21, 2012
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·January 7, 2013
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·January 7, 2013
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·December 4, 2012
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·November 21, 2012