Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SENOCLAIRE

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·INVENIA ABUS

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS Autoated Breast Ultrasound System

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS Premium, Invenia ABUS Prime

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS 2.0 Automated Breast Ultrasound System

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Senographe Pristina 3D

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Senographe Pristina 3D and SenoClaire

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·APPLICATION SOFTWARE, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD,GEM DR ICD,GEM II DR ICD,GEM I

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Pedi-padz Multifunction Electrodes, Pro-padz Cardiology W/LVP Gel Electrodes, Pro-padz Radiolucent Liquid Gel Electrodes

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·HYLAFORM (HYLAN B GEL), HYLAFORM PLUS, CAPTIQUE

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Mentor MemoryGel Silicone Gel-Filled Breast Implants

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL AF, GEM III FAMILY OF ICD'S

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Mentor MemoryGel Silicone Gel-Filled Breast Implants

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE REYNE and RESTYLANE DEFYNE INJECFTABLE GELS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Mentor MemoryShape Silicone Gel-Filled Breast Implants