11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740920450·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674092045060·
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252713128·Delta 1.7mm Panel 3x21 Ctrsinks x 0.75mm
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HIGHGATE CURVED ROD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENCOR MRI DRIVER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·September 8, 2022
ENDURANT II
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·May 3, 2013
LAMITRODE S8
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code GZB·August 27, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 18, 2011
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015