10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)
FDA 510(k)
FDA Class 2
·General Hospital
Sklar®
FDA UDI
SKLAR CORPORATION·10649111292088·SKLARLITE MAYO-HEGAR NH 7" SER
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
Allmed Surgical Face Masks (Ear loops)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
25 G X 1 IN. BD ECLIPSE¿ NEEDLE, FOR USE WITH BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·September 24, 2015
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·November 4, 2008
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·September 2, 2011
ACCU-CHEK ® MULTICLIX LANCETS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 17, 2013
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 25, 2024