Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ST AIA-PACK PA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

FDA classification

FDA Class 2 ·Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

FDA classification

FDA Class 2 ·Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

FDA classification

FDA Class 2 ·Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA classification

FDA Class 2 ·Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

FDA classification

FDA Class 2 ·Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

FDA classification

FDA Class 2 ·Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

FDA classification

FDA Class 2 ·Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

FDA classification

FDA Class 2 ·Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

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

FDA classification

FDA Class 2 ·Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

FDA classification

FDA Class 2 ·Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

FDA classification

FDA Class 2 ·Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

FDA classification

FDA Class 2 ·Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator