49 results · 26ms · Sources: EU EUDAMED, US FDA

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