FLUOREX DTA-400A

FDA 510(k)

FDA Class 2 ·Radiology

CareLink SmartSync Device Manager - Pacing System Analyzer

FDA 510(k)

FDA Class 2 ·Cardiovascular

VA 1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADAPTER CABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL EP-2 CLINICAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIEMENS-ELEMA PSA 376

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOTEST 2200

FDA 510(k)

FDA Class 2 ·Cardiovascular

MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180

FDA 510(k)

FDA Class 2 ·Cardiovascular

ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·BELOS VR-T ICD

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD'S)

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·BELOS VR ICD SYSTEM

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV-S/KENTROX SL-S ICD LEADS

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV LEAD SYSTEMS

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM