Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System™ (OCS™) Heart

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO SV AND OC OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA classification

FDA Class 3 ·Lithotripter, Shockwave (For Treating Gallbladder Stones)

Spinal Pedicle Screw, Fixation, Appliance System

FDA classification

FDA Class 3 ·Spinal Pedicle Screw, Fixation, Appliance System

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

FDA Pre-Market Approval

FDA Class 3 ·BRAVA CRT-D, QUAD CRT-D, CONCERTO OCD,CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, MAXIMO II CRT-D, PROTECT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS AND ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

LEAD MODIFICATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIPOLAR LEADS, DISP.

FDA 510(k)

FDA Class 3 ·Cardiovascular

PULSTRON MODEL 100

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PULSE DEVICES

FDA 510(k)

FDA Class 3 ·Cardiovascular

INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 493-03 PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACEMAKER, ELECTRODE, PERMANENT & TEMP.

FDA 510(k)

FDA Class 3 ·Cardiovascular

DIRECTIONAL BOOT

FDA 510(k)

FDA Class 3 ·Cardiovascular

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL

FDA 510(k)

FDA Class 3 ·Cardiovascular