ANGEION IGITAL ANGEFLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENCORE 26 ADVANTAGE KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

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

BC-5390 Auto Hematology Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

External Counterpulsation System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lunderquist Extra Stiff Wire Guide

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed ViewFlex Xtra ICE Catheter (D087031)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

FDA 510(k)

FDA Class 2 ·Cardiovascular

PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO

FDA 510(k)

FDA Class 2 ·Radiology

Disposable Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

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

Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter

FDA 510(k)

FDA Class 2 ·Cardiovascular