POLYSTAN HEATER-COOLER UNIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 9140 (SYSTEM ATHENA)

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 9266 SAO2 SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·Cardiovascular

9293/1 INTERFACE MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·General Hospital

TYPE 9292 INTERFACE CAPNOGRAPH

FDA 510(k)

FDA Class 2 ·Anesthesiology

TYPE 9040/NEO

FDA 510(k)

FDA Class 2 ·Cardiovascular

CALIBRATION KIT

FDA 510(k)

FDA Class 1 ·Anesthesiology

AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849

FDA 510(k)

FDA Class 2 ·Radiology

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 VR-T / Rivacor 7 VR-T /5VR-T /3 VR-T / Acticor 7 VR-T DX / Rivacor 7 VR-T DX /Rivacor 5 VR-T DX ; Acticor 7 DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Plexa ProMRI DF-1 S DX 65/17, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI S 60,

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX,

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX,

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-