Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD ADAPTOR/IS-1 CONNECTOR PORT PIN PLUG KIT/Y ADAPTOR/EXTENDER KIT/SPRINT LEAD DRUG COMBINATION/TRANSVENE DF1/RV LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Lead, Su

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead and Transvene CS/SVC L

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit, DF-1/IS-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, Lead Adaptor, Sprint Quatro Lead, Su

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE CS/SVC/DF1/RV/SUBQ/SVC

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD/Y ADAPTORS/IS-1 PORT PIN PLUG/SPRINT LEAD/QUATTRO/QUATTRO SECURE/QUATTRO SINGLE COIL/TRANSVENE SVC/DF-1/Y ADAPTOR

S.A.F. ACETABULAR CUP WITH POROUS COATING

FDA 510(k)

FDA Class 3 ·Orthopedic

POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

FMS MODEL 110

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

STERILE POLYHESIVE PBS DRESSING

FDA 510(k)

FDA Class 3 ·Unknown

KM-3 ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

ATH METAL:UHMWPE TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

POROUS-COATED TITANIUM ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED

FDA 510(k)

FDA Class 3 ·Orthopedic

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA