PowerDot PD-01MT

FDA 510(k)

FDA Class 2 ·Physical Medicine

AirKEE T900

FDA 510(k)

FDA Class 2 ·General Hospital

Bioptimal Bipolar Pacing Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Biofourmis Everion+ (G2)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AVA (Augmented Vascular Analysis)

FDA 510(k)

FDA Class 2 ·Radiology

ProSeal™ In Line Pump Set (423850)

FDA 510(k)

FDA Class 2 ·General Hospital

SMARTez elastomeric infusion pump

FDA 510(k)

FDA Class 2 ·General Hospital

Respiree Cardio-Respiratory Monitor

FDA 510(k)

FDA Class 2 ·Anesthesiology

Claritas iPET

FDA 510(k)

FDA Class 2 ·Radiology

THERMODILUTION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

F88 URE-SD/RD Flexible Ureteroscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLANCET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SERV MEDICAL CDSS

FDA 510(k)

FDA Class 2 ·Radiology

SuperSlyde Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm

FDA 510(k)

FDA Class 2 ·Anesthesiology

Assistant's Chair

Basic UDI-DI

EU MDR · Eu Md Class 1 ·UFSK-International OSYS GmbH·8 devices

Instrument Table

Basic UDI-DI

EU MDR · Eu Md Class 1 ·UFSK-International OSYS GmbH·1 device

Transport- and relaxing chair

Basic UDI-DI

EU MDR · Eu Md Class 1 ·UFSK-International OSYS GmbH·1 device

Transport- and relaxing chair

Basic UDI-DI

EU MDR · Eu Md Class 1 ·UFSK-International OSYS GmbH·1 device

Surgeon's Chair

Basic UDI-DI

EU MDR · Eu Md Class 1 ·UFSK-International OSYS GmbH·8 devices