8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC
FDA 510(k)
FDA Class 2
·General Hospital
THE ANSWER SCREW SUPPLEMENTATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·October 1, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·June 17, 2011
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017