16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TDM N-ACETYLPROCAINAMIDE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CANNULATED PLUS SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WHEELCHAIR, MODELS H001A, 4422
FDA 510(k)
FDA Class 1
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2025
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·April 5, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORP·Product code LZG·April 8, 2011
TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PERFUSION SYSTEMS·Product code DTZ·June 11, 2008
BIOKNOTLESS ANCHORS
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·March 4, 2008
BIOKNOTLESS ANCHOR
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·March 4, 2008
BIOKNOTLESS ANCHOR
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·March 4, 2008
BIOKNOTLESS ANCHOR
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·March 4, 2008
BIOKNOTLESS ANCHOR
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·March 4, 2008
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
FDA Adverse Event
Death
·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
FDA Adverse Event
Death
·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023
Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage¿ TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage¿ TOX Drug Screen Control 1 or Alere Triage¿ TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen Controls are to be used with the Alere Triage¿ TOX Drug Screen tests and Alere Triage¿ Meters to assist the laboratory in monitoring test performance.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·October 30, 2013
Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage TOX Drug Screen Control 1 or Alere Triage TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen Controls are to be used with the Alere Triage TOX Drug Screen tests and Alere Triage Meters to assist the laboratory in monitoring test performance.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code DIF·September 23, 2013