Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE DEVICE

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS

CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

SPINAL STABILIZING SPHERE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

PIKOS LP 01, PIKOS LP E01

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT

FDA 510(k)

FDA Class 3 ·Cardiovascular

SPINAL SPHERES

FDA 510(k)

FDA Class 3 ·Unknown

MEDTRONIC MODEL 4558M

FDA 510(k)

FDA Class 3 ·Cardiovascular

SATELLITE SPINAL SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING

FDA 510(k)

FDA Class 3 ·Cardiovascular

PIKOS E 01-B

FDA 510(k)

FDA Class 3 ·Cardiovascular

PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS

FDA 510(k)

FDA Class 3 ·Cardiovascular

CARDIFIX ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MAXIMA FILTERED HARDSHELL RESERVOIR

FDA 510(k)

FDA Class 3 ·Cardiovascular

PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular