D300 DOME

FDA 510(k)

FDA Class 2 ·Cardiovascular

BARRX FLEX RFA ENERGY GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CPS-1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NIC 1800 NEEDLE DISPOSAL SYSTEM

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

AGILIS NXT STEERABLE INTRODUCER, MODEL G408324

FDA 510(k)

FDA Class 2 ·Cardiovascular

Impulse Angiographic Catheter, Expo Angiographic Catheter

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

EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2

FDA 510(k)

FDA Class 2 ·Cardiovascular

Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323

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