HAND-HELD IRRIGATION PUMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electric Nasal Aspirator (BC026, BC025, BC023)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SERIES 3 GENERAL SUCTION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rex Medical Aspiration Pump

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Renova RP Centesis Pump

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

Enivo™

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UIMAT PUMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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