Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm 24 HV, Juvederm 30 and Juvederm 30HV Gel Implants

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Gel-Flow NT, Gelfoam Powder, Gelfoam Sponge, Gelfoam Compressed Sponge

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa+ with Lidocaine 1.0 mL, Revanesse Versa+ with Lidocaine

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Natrelle Saline-Filled Breast Implants

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE-PERLANE-RESTYLANE-L/PERLANE-L AND RESTYLANE-SILK INJECTABLE GELS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·HYLAFORM FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 LEADS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ACUITY STEERABLE IS-1 LEADS

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann® Emdogain®

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·FETAL ACOUSTIC STIMULATOR (FAST)

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR