INFINITECH SOFT TIP FLUTE NEEDLE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SAFETY RELEASE ARCH BAR KIT

FDA 510(k)

FDA Class 2 ·Dental

PROLITE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO FLUOROTEX II SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STORZ PREMIERE(R) MICROSURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

Clinical Electronic Thermometer

FDA classification

FDA Class 2 ·Clinical Electronic Thermometer

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

FDA classification

FDA Class 2 ·Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Physiological Signal Based Seizure Monitoring System

FDA classification

FDA Class 2 ·Physiological Signal Based Seizure Monitoring System

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

Vessel Guard Or Cover

FDA classification

FDA Class 2 ·Vessel Guard Or Cover

Saline, Vascular Access Flush

FDA classification

FDA Class 2 ·Saline, Vascular Access Flush

Heparin, Vascular Access Flush

FDA classification

FDA Class 2 ·Heparin, Vascular Access Flush

Water, Vascular Access Flush

FDA classification

FDA Class 2 ·Water, Vascular Access Flush

Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

FDA classification

FDA Class 2 ·Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

Outpatient Cardiac Telemetry

FDA classification

FDA Class 2 ·Outpatient Cardiac Telemetry

Continuous, Ventilator, Home Use

FDA classification

FDA Class 2 ·Continuous, Ventilator, Home Use

Cap, Device Disinfectant

FDA classification

FDA Class 2 ·Cap, Device Disinfectant

Catheter, Peritoneal, Long-Term Indwelling, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal, Long-Term Indwelling, Exempt