79 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUSON P600 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
FINN KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304268845·
ProFil
FDA UDI
SILMET LTD·07290015358507·Dental Composite Restorative
OsteoMed
FDA UDI
OSTEOMED LLC·00845694004855·74 x 50mm Mesh Plate
Drill Sleeve
FDA UDI
I.T.S. GmbH·09120047297261·Drill Sleeve, D=1.7mm, Distal Femur a. Tibia
PASSIVE WASTE GAS SCAVENGER, MODEL 14600
FDA 510(k)
FDA Class 2
·Anesthesiology
BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Distraction Paddle - 7mm
FDA UDI
CAPTIVA SPINE, INC.·00850065741628·Distraction Paddle - 7mm
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL MUREX Anti-HBs Verifiers
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON XL MUREX Anti-HBs; LIAISON XL MUREX Control Anti-HBs; LIAISON XL Murex Anti-HBs Verifiers
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
FDA Pre-Market Approval
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs, LIAISON® XL Murex Anti-HBs Verifier
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON XL Murex Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifier
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON XL Murex Anti-HBs, LIAISON XL Murex Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifiers