AIW WATER SYSTEM FOR HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)

FDA 510(k)

FDA Class 2 ·General Hospital

IMAGE WORKS PANOURA

FDA 510(k)

FDA Class 2 ·Dental

ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PALMER OBSTETIC BRACE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LEADLINER CS LEAD DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

External Counterpulsation System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed ViewFlex Xtra ICE Catheter (D087031)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Reprocessed CS Diagnostic Electrophysiology Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled

FDA 510(k)

FDA Class 2 ·Cardiovascular

Attain Hybrid Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable High Pressure Syringe

FDA 510(k)

FDA Class 2 ·Cardiovascular

Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENZYMATIC ALPHA-AMYLASE REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMYLASE TEST (AMYL) ITEM NUMBER: 65653

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OLYMPUS AMYLASE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry