44 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
POLY-TAPE, 20 X 500MM
FDA Adverse Event
Injury
·XIROS·Product code JDR·December 6, 2011
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964054639·Endo Carry-on Procedure Kit Includes Basin, Enz...
VECTOR TAS
FDA UDI
ORMCO CORPORATION·10889989000235·VectorTAS BONDABLE DELTA BUTTON - Flat Qty 6
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521010051D0·10 x 50 mm SI Implant with HA Coating
COMFORT
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 23, 2025
Klaitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100150·Counter Torque, Low Profile Assembly
ACTICOAT FOAM DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
RX EVEREST
FDA 510(k)
FDA Class 2
·Dental
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·IMMULITE 2000 XPI ANTI-HBC
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE 2000/2000 XPi Anti-HBc
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE® 2000 Anti-HBc
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE 2000 Anti-HBc
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ANTI-HBC IMMULITE SUBSTRATE REAGENT
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC ASSAYS
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE 2000 Anti-HBc
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE 2000 Systems Total Antibodies to Hepatitis B Core Antigen (Anti-HBc)