70 results · 75ms · 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.

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