THREADED PINS

FDA 510(k)

FDA Class 3 ·Unknown

KM-3 ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

ELA MEDICAL UNILITH PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

SUTURELESS MYOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

THOMPSON TYPE HIP PROTHESIS

FDA 510(k)

FDA Class 3 ·Orthopedic

MOTIONSPECT

FDA 510(k)

FDA Class 3 ·Unknown

KM-4(TM) METAL-BACKED ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED

FDA 510(k)

FDA Class 3 ·Orthopedic

KIRSCHNER SELF-TAPPING ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR/VIRTUOSO/ENTRUST/MARQUIS/MAXIMO/INTRINSIC ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia, Brava, Claria, Compia, Consulta, Maximo, Protecta XT MRI/CRT-D, Viva Quad S AF VR ICD

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

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM II/MARQUIS/MAXIMO/II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO/II DR/VR/SECURA DR/VR ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera S, Maximo II, Protecta, Secura,Quad XT CRT-D; Virtuoso II, Visia AF, MRI VR ICD,

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN EL. DYNAGEN MINI, INOGEN EL, INOGEN MINI, ORIGEN EL, ORIGEN MINI ICD'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ICD FIRMWARE VERSION 6.6.7 FOR EPIC, EPIC +, ATLAS AND ATLAS +, AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC ICDS, CONCERTO - VERTUOSO V1.0 SOFTWARE -SW002, CONEXUS ACTIVATOR 27901

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS