8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
INTERP-1000
FDA 510(k)De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123793·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 150mm
Perifit
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INFILL GRAFT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
TRILOGY SHELL WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER·Product code LPH·January 9, 2013
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 6, 2014
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