56 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WORRY-REMOVER IRRIGATOR
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Tornier Latitude
FDA UDI
TORNIER, INC.·00846832014842·HUMERAL GUSSET BROACH
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0300060·Egg Handle, 1.75" Fixed Qtr Sq Cann Imp Crimson
SCFE Screw
FDA UDI
ORTHOPEDIATRICS CORP.·00841132114278·4.0mm X 56mm MED THREAD CANNULATED SCREW
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420300560·Anterio Lateral Closing Wedge Osteotomy Guide, ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410300560·Anterior Closing Wedge Osteotomy Guide, 30mm x ...
BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS
BI-METRIC LAT PC 13X145MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWZ·November 9, 2016
BI-METRIC LAT PC 12X140MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·November 9, 2016
BI-METRIC LAT PC 11X135MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·November 9, 2016
BI-METRIC LAT PC 10X130MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·November 9, 2016
BI-METRIC LAT PC 9X125MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWZ·November 9, 2016
SPIDERCUP
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code PBI·January 3, 2019
SPIDERCUP
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code PBI·January 3, 2019
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur HCV, and Atellica HCV
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HCV ASSAY
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur and Atellica IM HCV