7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
URO-PRO 2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RELYX RMGIP
FDA 510(k)
FDA Class 2
·Dental
LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NELLCOR PURITAN BENNETT NPB-40
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·June 2, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·December 13, 2010
1.25MM CERCLAGE WIRE COILS 10 METERS
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code JDQ·January 18, 2013
Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse Panel Plus TCA (K973784), & Triage Drugs of Abuse Panel Plus PPX (K014247) Model Number: 90008, 92002, & 92000 Type of Packaging (i.e. box, plastic bag): For all affected device types: 25 individually pouched devices in a labeled kit box. The Triage Drugs of Abuse Panel plus Tricyclic Antidepressants utilizes a patented immunochemistry, ASCENDTM MULTIMMUNOASSAY (AMIATM). Each AMIATM assay is a competitive binding immunoassay in which a chemically labeled drug (drug conjugate) competes with drug which may be present in the urine for antibody binding sites. After a brief incubation, the reaction mixture is transferred to the membrane in the Detection Area. Free drug conjugate that is displaced from antibody binding sites by drug in the urine, binds to a zone of monoclonal antibody that is immobilized on the membrane. The membrane is washed to remove the unbound conjugate and clear the background. Test results are visually read. The Triage Drugs of Abuse Panel plus Tricyclic Antidepressants is an immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse, (Phencyclidine, Benzodiazepines, Cocaine Metabolite, Amphetamines, THC, Opiates, Barbiturates), and Tricyclic Antidepressants in urine.
FDA Recall
Terminated
·Alere San Diego·Product code DIS·January 4, 2012