Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RESCAN

FDA 510(k)

FDA Class 2 ·Anesthesiology

iSchemaView RAPID

FDA 510(k)

FDA Class 2 ·Radiology

WR3500 AND WR3600 SERIES RECORDERS

FDA 510(k)

FDA Class 1 ·Cardiovascular

STAR CALC

FDA 510(k)

FDA Class 2 ·Anesthesiology

ELECTONE/PA RECHARGEABLE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

INTEGRITI PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zap-X Radiosurgery System

FDA 510(k)

FDA Class 2 ·Radiology

8X-10-6XXX Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRS CRANIAL BONE VOID FILLER(TRS C-BVF)

FDA 510(k)

FDA Class 2 ·Neurology

PREMIER ASP/CD RECHARGEABLE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

SURGEN VALVE

FDA 510(k)

FDA Class 2 ·General Hospital

INWAVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

C900 X-RAY FILM PROCESSOR

FDA 510(k)

FDA Class 2 ·Radiology

Ankle Support

Basic UDI-DI

EU MDR · Eu Md Class 1 ·JEM Healthcare Co., Ltd.·1 device

Tape

Basic UDI-DI

EU MDR · Eu Md Class 1 ·JEM Healthcare Co., Ltd.·43 devices

Bandage

Basic UDI-DI

EU MDR · Eu Md Class 1 ·JEM Healthcare Co., Ltd.·12 devices

Hot Cold Pack

Basic UDI-DI

EU MDR · Eu Md Class 1 ·JEM Healthcare Co., Ltd.·1 device