QuadraSphere Microspheres

FDA 510(k)

FDA Class 2 ·Cardiovascular

Torpedo Gelatin Foam

FDA 510(k)

FDA Class 2 ·Cardiovascular

Embosphere Microspheres

FDA 510(k)

FDA Class 2 ·Cardiovascular

EmboCube Embolization Gelatin

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL #5000 PULMO PLUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER

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

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KAINOX RV-S/ KAINOX VCS ICD LEADS

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170