Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRFLEX PREMOUNTED CORONARY STENT SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·IGEL 67 CONTACT LENS

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2100 SYSTEM

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace® and Sentimag® Magnetic Locatization System (PUV)

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace and Sentimag Magnetic Locatization System (PUV)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRXCELL COCR CORONARY SENT ON RX

Barrier, Std, Oral Sex

FDA classification

FDA Class 2 ·Barrier, Std, Oral Sex

Savantini Ltd

Manufacturer

4 Basic UDI-DIs·14 Devices

Cumbre International Limited

Manufacturer

🇲🇾 Malaysia

Essential Dental Systems

Manufacturer

🇺🇸 United States·1 Importer

Helica Instruments Ltd

Manufacturer

1 Importer

Guangzhou HEAS BioTech Co., Ltd.

Manufacturer

🇨🇳 China

Open Bionics Ltd.

Manufacturer

12 Basic UDI-DIs·12 Devices

Closed Loop Medicine Ltd.

Manufacturer

DName-iT Holdings Ltd

Manufacturer

1 Basic UDI-DI·1 Device

Enable Design Ltd

Manufacturer

2 Basic UDI-DIs·6 Devices

Predictive Health Intelligence Ltd

Manufacturer

1 Basic UDI-DI·1 Device

Rapidex Ltd

Manufacturer

1 Importer