275 results
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20ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 3
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Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·MagtraceTM and Sentimag(R) Magnetic Locatization System
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·MagtraceTM and Sentimag(R) Magnetic Locatization System
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·MagtraceTM and Sentimag(R) Magnetic Locatization System
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·MagtraceTM and Sentimag(R) Magnetic Locatization System
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·MagtraceTM and Sentimag(R) Magnetic Locatization System
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace® and Sentimag® Magnetic Locatization System (PUV)
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace® and Sentimag® Magnetic Locatization System (PUV)
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace and Sentimag Magnetic Locatization System (PUV)
Gases Used Within Eye To Place Pressure On Detached Retina
FDA Pre-Market Approval
FDA Class 3
·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
Gases Used Within Eye To Place Pressure On Detached Retina
FDA Pre-Market Approval
FDA Class 3
·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery
Stimulator, Autonomic Nerve, Implanted (Depression)
FDA Pre-Market Approval
FDA Class 3
·VNS THERAPY SYSTEM
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Amplia MRI CRT-D, Quard CRT-D; Brava CRT-D, Quard CRT-D; Claria MRI CRT-D, Quard CRT-DCompia MRI CRT-D, Quard CRT-D; Con
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·VNS THERAPY SYSTEM
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS Total Knee System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MODEL 7223CX MICRO JEWEL II(TM)
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·Access AFP Reagents on the Access Immunoassay Systems
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·cobas HPV
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech PSA Reagents on the Access Immunoassay Systems