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

FDA Pre-Market Approval

FDA Class 2 ·IMX AND AXSYM PSA

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX AFP ASSAY

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX TOTAL PSA

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX(R) PSA*

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX TACROLIMUS II

ISOAID ADVANTAGE PD-103, MODEL IAPD-103A

FDA 510(k)

FDA Class 2 ·Radiology

HAND HELD MEDISPACER

FDA 510(k)

FDA Class 2 ·Anesthesiology

HAYMAX

FDA 510(k)

FDA Class 2 ·General Hospital

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

PROTEX, TAHITI CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LEADLINER CS LEAD DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)

FDA 510(k)

FDA Class 2 ·Cardiovascular

extriCARE® 3000 Negative Wound Pressure Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SpermAlign Sperm Separation Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Air Next

FDA 510(k)

FDA Class 2 ·Anesthesiology

RANEY CLIPS

FDA 510(k)

FDA Class 2 ·Neurology