49 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Tissue Adhesive For Ophthalmic Use
FDA classification
FDA Class 3
·Tissue Adhesive For Ophthalmic Use
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA ASSAY
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT TOTAL PSA ASSAY
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·MRICS AND LZ OCTAD LEAD FAMILIES
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede® System
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 2000+ LOW INTENSITY FRACTURE HEALING SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 4000+BONE HEALING SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 2000+
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 3000
Cap, Cervical, Contraceptive
FDA Pre-Market Approval
FDA Class 3
·PRENTIF TM CAVITY RIM CERVICAL CAP
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN ULTRASOUND BONE HEALING SYSTEM
Cap, Cervical, Contraceptive
FDA Pre-Market Approval
FDA Class 3
·LEA'S SHIELD BARRIER CONTRACEPTIVE
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 4000+BONE HEALING SYSTEM
Cap, Cervical, Contraceptive
FDA Pre-Market Approval
FDA Class 3
·FEMCAP BARRIER CONTRACEPTIVE
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum
FDA Pre-Market Approval
FDA Class 3
·AFP MID-PREGNANCY REFERENCE PREPARATION
Cap, Cervical, Contraceptive
FDA Pre-Market Approval
FDA Class 3
·FEMCAP CONTRACEPTIVE BARRIER DEVICE