LUMI-AGGREGOMETER

FDA 510(k)

FDA Class 2 ·Hematology

PLATELET AGGREGATION REAGENTS

FDA 510(k)

FDA Class 2 ·Hematology

CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A

FDA 510(k)

FDA Class 2 ·Hematology

CADENS (TM) COLON

FDA 510(k)

FDA Class 2 ·Radiology

AGGREGOMETER, DUAL CHANNEL PLATELET

FDA 510(k)

FDA Class 2 ·Hematology

PLATELET AGGREGOMETERS

FDA 510(k)

FDA Class 2 ·Hematology

AGGRO/LINK VW COFACTOR SOFTWARE

FDA 510(k)

FDA Class 2 ·Hematology

DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Deployable Oxygen Generation System-Smaill (DOGS-S)

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·350 SERIES/ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE CS/SVC LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/PIROUET S+

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/CAPSURE MODEL/PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT

FDA Pre-Market Approval

CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/CAPSURE Z NOVUS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE) ACE/ACE 5434T/ACE HEADER/LEAD END PIN CAP

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CATH RF CONDUCTR/5 MM 8FR/RF MC 078 6022/CONTACTR CATHETER 7 FR 5MM/RF CONDUCTR MC SELF-REFERENCE CATHETER/RF ENHANCR II