10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXACTECH OPTETRAK UNICONDYLAR KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
BABY DOPPLEX 3000 MK 2 (BD3000)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SENOJ IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
COMPLETE
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020
MEDFUSION® 3500 SYRINGE PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·November 28, 2017
ULTAMET MTL INS NEUT 36MM 52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS·Product code KWA·April 8, 2013
NA
FDA Adverse Event
Injury
·Product code LZS·May 9, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 6, 2011
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018