14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
FDA 510(k)
FDA Class 2
·Anesthesiology
Conformis Hip System
FDA UDI
Conformis, Inc.·00810933030124·REAMER, ACETABULAR, 57MM FULL
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481113499·LOCATOR R-Tx Abutment for 3.8mm Conelog Connect...
SPIFE CHOLESTEROL PROFILE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·March 30, 2023
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·April 20, 2011
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·April 26, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 29, 2014
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·April 22, 2011
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·June 8, 2023
Misys Commercial Laboratory, Laboratory Information System, version 3.4.1
FDA Recall
Terminated
·Misys Healthcare Systems·March 24, 2003
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018