Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC MAXXUM PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK MONORAIL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW, MAVERICK MONORAIL & MAVERICK2 MONORAIL PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL AND OVER-THE-WIRE PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK MONORAIL PTCA CATHETER SYSTEM AND MAVERICK2 MONORAIL PTCA CATHETER SYSTEM

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

On-Body Injector

FDA classification

FDA Class 2 ·On-Body Injector

Electric Breast Pump, model: YM-8166

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

FDA classification

FDA Class 2 ·Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

FDA classification

FDA Class 2 ·Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

Device For Sleep Apnea Testing Based On Mandibular Movement

FDA classification

FDA Class 2 ·Device For Sleep Apnea Testing Based On Mandibular Movement

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

FDA classification

FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification

FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission