9 results
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19ms
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Sources: EU EUDAMED, US FDA
IRMA TEST, NORDICLAB FERRITIN
FDA 510(k)
FDA Class 2
·Immunology
Ingenia
FDA UDI
Philips Medical Systems Nederland B.V.·00884838115682·Enables trained physicians to obtain cross-sect...
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G586E7821570·joseph nasal knife, double-edged, 6" (15.2 cm),...
KETTOSIL AND SILGINAT
FDA 510(k)
FDA Class 2
·Dental
BioSign Flu A+B
FDA 510(k)
FDA Class 2
·Microbiology
M2A-MAGNUM 42-50MM TPR INSRT-6
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 30, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 11, 2012
GYNECARE MESH UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·May 19, 2015
Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017