LOW PROFILE TITANIUM MODEL CATALOG #1003

FDA 510(k)

FDA Class 2 ·General Hospital

LOW FLOW OSV II HYDROCEPHALUS VALVE

FDA 510(k)

FDA Class 2 ·Neurology

ULTRA LOW POROSITY DACRON WOVEN PATCH

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMERICAN HEYER-SCHULTE LOW PROFILE VALVE

FDA 510(k)

FDA Class 2 ·Neurology

THEREX LOW-PROFILE PORT - TITANIUM MODEL

FDA 510(k)

FDA Class 2 ·General Hospital

Fidmi Low Profile Enteral Feeding Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNTHES (USA) LOW-PROFILE WRIST FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

SHILEY LOW PRESSURE THIN-CUFFED TRACH.

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VisuCon-F Low Fibrinogen Control Plasma

FDA 510(k)

FDA Class 2 ·Hematology

4' LOW VOLUME IV EXTENSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

AIRTEC2 LOW AIR LOSS THERAPY BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

THEREX LOW PROFILE PORT-TITANIUM MODEL

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL (MR), MAVERICK OVER-THE-WIRE (OTW), QUANTUM MAVERICK MR AND OTW

AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL (MR), FLEXTOME CUTTING BALOON OTW, CUTTING BALLOON ULTRA2 MR/OTW

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·VOYAGER OTW CORONARY DILATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·D114S OTW BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW/RANGER PTCA CATHETERS