Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMX PSAS

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT IMX SA

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT IMX FREE PSA

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT IMX FREE PSA

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus, Juvéderm Ultra Plus XC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Voluma XC, Juvéderm Vollure XC, Juvederm Volbella XC

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT IMX TOTAL PSA, ABBOTT AXSYM TOTAL PSA AND ABBOTT ARCHITECT TOTAL PSA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Ovation iX Abdominal Stent Graft System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Ovation iX Abdominal Stent Graft System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·OVATION IX ABDOMINAL STENT GRAFT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Ovation iX Abdominal Stent Graft System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Ovation iX Abdominal Stent Graft System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Ovation iX Abdominal Stent Graft System

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP and Impella RP with SmartAssist

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP, Impella RP with SmartAssist

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System