12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARIX HAND SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131566·TiBase BLX RB/WB 3.5G E
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
FDA 510(k)
FDA Class 2
·General Hospital
VITEK 2 YEAST CASPOFUNGIN
FDA 510(k)
FDA Class 2
·Microbiology
SYNDEO SYRINGE PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code MEA·October 8, 2009
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code FSA·October 1, 2014
6000 CMS IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 17, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011
ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020
NUTRILINE
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·December 13, 2021
NUNTRILINE
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·February 9, 2022
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019