13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NEEDLE 30X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 23, 2020
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
FDA 510(k)
FDA Class 2
·Hematology
ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400
FDA 510(k)
FDA Class 2
·Cardiovascular
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code ESW·August 11, 2011
TI MATRIXNEURO SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·July 2, 2013
SARS-COV-2-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code QKO·October 20, 2021
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·March 12, 2021
SARS-COV-2-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code QKO·October 27, 2020
SARS-COV-2-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code QKO·January 27, 2021
SARS-COV-2-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code QKO·January 15, 2021
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016