Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR

Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite

FDA classification

FDA Class 3 ·Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite

Dilator, Cervical, Expandable

FDA classification

FDA Class 3 ·Dilator, Cervical, Expandable

Monitor, Electroencephalographic, Fetal (And Accessories)

FDA classification

FDA Class 3 ·Monitor, Electroencephalographic, Fetal (And Accessories)

Fluid, Cytological Collection

FDA classification

FDA Class 3 ·Fluid, Cytological Collection

Stimulator, Fetal, Acoustic

FDA classification

FDA Class 3 ·Stimulator, Fetal, Acoustic

Band, Tubal Occlusion

FDA classification

FDA Class 3 ·Band, Tubal Occlusion

Oximeter, Fetal Pulse

FDA classification

FDA Class 3 ·Oximeter, Fetal Pulse

Cap, Cervical, Contraceptive

FDA classification

FDA Class 3 ·Cap, Cervical, Contraceptive

Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use

FDA classification

FDA Class 3 ·Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use

Condom, Female, Animal Tissue

FDA classification

FDA Class 3 ·Condom, Female, Animal Tissue

Barrier, Absorbable, Adhesion

FDA classification

FDA Class 3 ·Barrier, Absorbable, Adhesion

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA classification

FDA Class 3 ·Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

Sensor, Electro-Optical (For Cervical Cancer)

FDA classification

FDA Class 3 ·Sensor, Electro-Optical (For Cervical Cancer)

Transcervical Contraceptive Tubal Occlusion Device

FDA classification

FDA Class 3 ·Transcervical Contraceptive Tubal Occlusion Device

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA classification

FDA Class 3 ·Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

Dilator, Cervical, Vibratory

FDA classification

FDA Class 3 ·Dilator, Cervical, Vibratory

Prosthesis, Suture, Cerclage

FDA classification

FDA Class 3 ·Prosthesis, Suture, Cerclage

Laparoscopic Contraceptive Tubal Occlusion Device

FDA classification

FDA Class 3 ·Laparoscopic Contraceptive Tubal Occlusion Device