ß-Galactocerebrosidase (Galc) Newborn Screening Test System

FDA classification

FDA Class 2 ·ß-Galactocerebrosidase (Galc) Newborn Screening Test System

2 CM PERIPHERAL CUTTING BALOON

FDA 510(k)

FDA Class 2 ·Cardiovascular

Neuronaute

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) ACE(TM) 1CM TIP PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·OLYMPIX & SLEUTH XT PTCA CATHETERS W/3CM BALLOONS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·OLYMPIX & SLEUTH XT PTCA CATHETERS W/4CM BALLOONS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SLEEK PTCA DILATATION CATHETERS W/3 & 4CM BALLONS

Neuronaute with IceCap 2 & IceCap 2 Small

FDA 510(k)

FDA Class 2 ·Neurology

NERVE STIMULATOR Q10

FDA 510(k)

FDA Class 2 ·Anesthesiology

PILOT CARDIOVASCULAR SYSTEMS 2 CM PILOT WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

1/2 CM REAR TIP EXTENDER (RTE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Neuronaute Plus

FDA 510(k)

FDA Class 2 ·Neurology

MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACU-DERM TRANSPARENT INCISE DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MASK, SURGICAL, DISP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THE ACME MEDICAL AESTHETIC ND:YAG LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SLIDEWIRETM(TRADEMARK PENDING)

FDA 510(k)

FDA Class 2 ·Cardiovascular