70 results
·
75ms
·
Sources: EU EUDAMED, US FDA
CLEAR CARE
FDA Adverse Event
ALCON LABORATORIES, INC.·Product code LPN·December 27, 2018
ACCESS® 2 SUBSTRATE
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LDT·December 12, 2011
ACCESS WASH BUFFER II SOLUTION
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LDT·October 20, 2011
LH 700 SERIES RETIC PAK
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC·Product code GGK·June 11, 2011
HEALON PRO
FDA Adverse Event
Injury
·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code LZP·June 26, 2018
ONE TOUCH ULTRA
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·March 21, 2006
EASYPUMP II
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code MEB·July 10, 2023
ACCESS WASH BUFFER II SOLUTION
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LDT·January 10, 2012
ACCESS WASH BUFFER II SOLUTION
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LDT·February 23, 2012
SYSMEX CA-650 COAGULATION ANALYZER
FDA Adverse Event
Malfunction
·SYSMEX CORP.·Product code GKP·December 8, 2014
EASYPUMP® II
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code MEB·March 8, 2016
TRUCOLOR WRIGHT STAIN
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKL·September 23, 2011
TRUCOLOR WRIGHT STAIN
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code KQC·September 23, 2011
LAMINAR
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·March 31, 2024
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015
HEALON PRO 0,85 ML
FDA Adverse Event
Malfunction
·AMO UPPSALA AB·Product code LZP·October 28, 2025
LAMINAR
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·March 25, 2024
LAMINAR
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·March 31, 2024
LAMINAR
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·March 25, 2024
LAMINAR
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·March 28, 2024