StepOne Ltd

FDA registration

IMMETECH INDUSTRIAL CO.,LTD·1 product·🇨🇳 China

Axis-Shield Diagnostics Ltd

Manufacturer

2 Importers

Alere San Diego, Inc.

Manufacturer

🇺🇸 United States·1 Importer

Abbott Diagnostics Scarborough, Inc.

Manufacturer

🇺🇸 United States·1 Importer

AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FDA Pre-Market Approval

ORIGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4 CRT-D; DYNAGEN CRT-D, X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Cardiac Resynchronization Therapy Defibrillator (CRT-D), Dynagen CRT-D/X4 CRT-D, Inogen CRT-D/X4 CRT-D, Origen CRT-D/X4

Sinobot X1

FDA registration

Sinovation (Beijing) Medical Technology Co., Ltd·1 product·🇨🇳 China

CO2 Sidestream Sensor

FDA registration

BEIJING KINGST COMMERCIAL & TRADE CO., LTD.·1 product·🇨🇳 China

CO2 Mainstream Module

FDA registration

BEIJING KINGST COMMERCIAL & TRADE CO., LTD.·1 product·🇨🇳 China

PC-900B

FDA registration

BEIJING KINGST COMMERCIAL & TRADE CO., LTD.·2 products·🇨🇳 China

QUICK CHANGE MONTGOMERY STRAP

FDA 510(k)

FDA Class 1 ·General Hospital

GENERAL PURPOSE KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UTILITY CLAMP

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

MULTI-PURPOSE HOLDER

FDA 510(k)

OXYGEN DELIVERY MEASURING DEVICE

FDA 510(k)

FDA Class 1 ·Anesthesiology

A Breathing System (ABS)

FDA 510(k)

FDA Class 2 ·Neurology

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

FDA 510(k)

FDA Class 2 ·Anesthesiology

Exact Medical

FDA UDI

EXACT MEDICAL MANUFACTURING, INC.·00850024023574·Gown, Surgical AAMI Level 4 XX-Large w/ Towel

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP