8,232 results
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40ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALCOTEST 7110 MKIII-C
FDA Adverse Event
Other
·DRAEGER SAFETY DIAGNOSTIC·Product code DJZ·August 26, 2011
SOBERLINK CONNECT DEVICE
FDA Adverse Event
Injury
·SOBERLINK HEALTHCARE LLC·Product code DJZ·September 27, 2022
INTOXILYZER
FDA Adverse Event
Injury
·MPD, INC. / REGISTERED NAME: CMI, INC.·Product code DJZ·October 22, 2007
1933078-1998-00001
FDA Adverse Event
Other
·Product code DJZ·June 19, 1998
BREATHALYZER
FDA Adverse Event
Injury
·Product code DJZ·September 10, 2007
IPG 37800
FDA Adverse Event
Malfunction
·ENTERRA MEDICAL·Product code DJZ·October 19, 2023
ALCOSENSOR III AND IV
FDA Adverse Event
Death
·INTOXIMETERS, INC.·Product code DJZ·May 11, 1998
SOBERLINK CONNECT
FDA Adverse Event
Malfunction
·SOBERLINK HEALTHCARE LLC.·Product code DJZ·January 8, 2025
BACTRACK MOBILE
FDA Adverse Event
Injury
·UNKNOWN·Product code DJZ·February 26, 2025
SOBERLINK CONNECT
FDA Adverse Event
Malfunction
·SOBERLINK HEALTHCARE LLC.·Product code DJZ·January 8, 2025
SOBERLINK CONNECT
FDA Adverse Event
Malfunction
·SOBERLINK HEALTHCARE LLC·Product code DJZ·September 30, 2019
Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)
FDA Recall
Terminated
·Sakar International, Inc.·Product code DJZ·November 30, 2007
0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.
FDA Recall
Terminated
·WNCK, Inc·Product code DJZ·November 30, 2005
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.
FDA Recall
Terminated
·Acon Laboratories, Inc.·Product code DJZ·June 17, 2015
Devices, Breath Trapping, Alcohol
FDA classification
FDA Class 1
·Devices, Breath Trapping, Alcohol
DJF Med
FDA UDI
Acta Medical LLC·00850033629316·1000ml Enteral Feeding and Flush Bag
DJF Med
FDA UDI
Acta Medical LLC·00850033629293·1000ml Enteral Feeding Set
DJF Med
FDA UDI
Acta Medical LLC·00850033629323·1000ml Enteral Feed and Flush with Spike Feed
DJF Med
FDA UDI
Acta Medical LLC·00850033629309·500ml Enteral Feeding Set
DJO, LLC
FDA registration
DJO, LLC·106 products·🇺🇸 United States