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

ACCELOGRAPH

FDA 510(k)

FDA Class 2 ·Anesthesiology

TOF-GUARD TRANSMISSION MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL

FDA 510(k)

FDA Class 2 ·Physical Medicine

MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

MYOTEST DBS NERVE STIMULATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING

FDA 510(k)

FDA Class 2 ·Anesthesiology

ELPHA 2000

FDA 510(k)

FDA Class 2 ·Physical Medicine

MYOTEST - NERVE STIMULATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

PTA Scoring Balloon Dilatation Catheter

Basic UDI-DI

EU MDR · Eu Md Class 2a ·DK Medical Technology Co., Ltd.·33 devices

Coronary Scoring Balloon Dilatation Catheter

Basic UDI-DI

EU MDR · Eu Md Class 3 ·DK Medical Technology Co., Ltd.·16 devices

Peripheral Scoring Balloon Dilatation Catheter

Basic UDI-DI

EU MDR · Eu Md Class 2a ·DK Medical Technology Co., Ltd.·1 device

PTA High Pressure Balloon Dilatation Catheter

Basic UDI-DI

EU MDR · Eu Md Class 2a ·DK Medical Technology Co., Ltd.·1 device

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS

D/Km-1, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·D/Km-1, Antigen, Antiserum, Control