SOLOHEALTH STATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

MC2 Portable X-ray System

FDA 510(k)

FDA Class 2 ·Radiology

EHC500 DESKTOP PATIENT STATION, MODEL EHC500

FDA 510(k)

FDA Class 2 ·Cardiovascular

EUROPA™ Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

INFUSET W/HUBER NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

GS-1000 GRASPING FORCEP, 5MM, INSULATED

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

FDA classification

FDA Class 2 ·Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

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

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER

Sleep Appliances With Patient Monitoring

FDA classification

FDA Class 2 ·Sleep Appliances With Patient Monitoring

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER WITH 5MM TIP ELECTRODE

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 ·ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CORDIS WEBSTER DIAGNOSITIC/ABLATION DEFLECTABLE TIP CATHETER & CATHETER-THERMOCOUPLE OR THERMISTOR

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

FDA classification

FDA Class 2 ·Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

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

FDA Pre-Market Approval

FDA Class 2 ·ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA

Integrated Continuous Glucose Monitoring System For Professional Retrospective Use

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitoring System For Professional Retrospective Use