TOTAL PSA MICROTITER ELISA

FDA 510(k)

FDA Class 2 ·Immunology

BAYER PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACTIVE PSA ELISA (DSL-10-9700)

FDA 510(k)

FDA Class 2 ·Immunology

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx

FDA 510(k)

FDA Class 2 ·Anesthesiology

THE DIVACUP MENSTRUAL SOLUTION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NEUROMONICS TINNITUS TREATMENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05

FDA 510(k)

FDA Class 2 ·Hematology

AirPhysio Positive Expiratory Pressure (PEP) Device

FDA 510(k)

FDA Class 2 ·Anesthesiology

ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

THE MARGRON HIP REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GRADILEIDEN V TEST

FDA 510(k)

FDA Class 2 ·Hematology

PEPER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Circumplast Circumcision Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Patient Administration Set

FDA 510(k)

FDA Class 2 ·Radiology

BIOMECCA CARETAKER 1000 & 2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

Multi-Link X2 ECG Cable and Lead Wire System

FDA 510(k)

FDA Class 2 ·Cardiovascular