Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgergy

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-EBK PLUS ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-EBK PLUS

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-COREK PLUS ASSAY

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans

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

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE DEVICE

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Spiration® Valve System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·DISPOSABLE FALOPE-RING BAND APPLICATOR KITS

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·SIR-SPHERES

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·Light Adjustable Lens and Light Delivery Device

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK II BONE GROWTH STIMULATOR

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 System

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL Cochlear Implant System

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY AB ACETABULAR SYSTEM