23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BUTTERFLY PLATE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033575451·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033575505·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033575499·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033575482·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033575512·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033575468·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033575475·
PALFIQUE ESTELITE LV CLEAR
FDA 510(k)
FDA Class 2
·Dental
EXHALE RF PROBE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·Product code MIH·August 3, 2015
HEARTSINE SAMARITAN 300P AND PAD-PAK K014067
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 19, 2018
HEARTSINE SAMARITAN 300P AND PAD-PAK K014067
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·March 7, 2018
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 6, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code LWS·March 10, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 12, 2008
ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·June 4, 2014
ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·June 4, 2014
ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·June 4, 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