THE SAFETY 1ST DIGITAL PACIFIER

FDA 510(k)

FDA Class 2 ·General Hospital

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-l ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

eCordum Cardiac Monitor (eCordum CM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)

FDA 510(k)

FDA Class 2 ·Cardiovascular

REGIONAL OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface

FDA 510(k)

FDA Class 2 ·Cardiovascular

REGIONAL OXIMETER SYSTEM, MODEL 7600

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY

FDA 510(k)

FDA Class 2 ·Cardiovascular

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Family of Implantable Pulse Generators

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim Family of Implantable Pulse Generators

D SERIES ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM

YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02

FDA 510(k)

FDA Class 2 ·General Hospital

DIGITAL TEMPERATURE MONITOR; MODEL KY-01

FDA 510(k)

FDA Class 2 ·General Hospital

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL ADAPTER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, 44, S-4, S-8, 88, winged, Penta, Quattrode, Octrode, Dual 4, Sin

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS Extensions

Electronic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular