Emit® II Plus Buprenorphine Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Atellica CH Magnesium (Mg)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STABIDENT LOCAL ANESTHESIA SYSTEM

FDA 510(k)

FDA Class 1 ·Dental

EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHILDREN'S SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LATEX SURGICAL GLOVES,STERILE/NON STERILE MOD BRAN

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·Animas Vibe System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM(R)

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·Animas Vibe System

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM(R)

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·Animas, Vibe System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM