CANDELA MINIBRUSH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RIWO SYSTEM TRAYS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM

FDA 510(k)

FDA Class 2 ·Immunology

Acu-sInQ Complete Endoscope Cleaning Aid System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUTO SUTURE* ANTI-FOG DEVICE**

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLUID PUMP, CP #3

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COX DISPOSABLE ENDOSCOPE CLEANING BRUSH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEBS-07

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Daiwha Corp., Ltd.·1 device

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEA

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM (URINARY)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM (BOWEL)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III AT ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM II DR/GEM II VR/GEM III DR/GEM III VR/ENTRUST/INTRINSIC 30/INTRINSIC/MARQUIS DR/MARQUIS VR/MAXIMO II DR/MAXIMO II/MA

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO/CONCERTO II/CONSULTA DF4/CONSULTA/INSYNC II PROTECT/INSYNC III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/INSYNC II MA

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-P

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II