2,854 results · 19ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000 Free PSA and IMMULITE 2000 Free PSA

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

FDA Pre-Market Approval
FDA Class 3 ·FPSA IMMULITE ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 2000 FREE PSA

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 fPSA

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000/IMMULITE 2000 Free PSA

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE® 1000 Free PSA, IMMULITE® 2000 Free PSA

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ST JUDE MEDICAL MECHANICAL HEART VALVE

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

FDA Pre-Market Approval
FDA Class 3 ·Mentor MemoryShape Breast Implants

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

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

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-One

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

FDA Pre-Market Approval
FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest Wearable Defibrilator

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-One

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM VOLUMA XC

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

FDA Pre-Market Approval
FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

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

FDA Pre-Market Approval
FDA Class 3 ·MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

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

FDA Pre-Market Approval
FDA Class 3 ·Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·COAPTITE INJECTABLE IMPLANT