Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CHARTER LABS SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CHARTER LABS SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CHARTER LABS SALINE SOLUTION

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER NAV DS

Amalgam Rx, Inc

Manufacturer

🇺🇸 United States·Intertek Medical Notified Body AB

SmileSonica Inc.

Manufacturer

🇨🇦 Canada·Intertek Medical Notified Body AB

Agfa HealthCare NV

Manufacturer

🇧🇪 Belgium·2 Basic UDI-DIs·2 Devices·Intertek Medical Notified Body AB

Sri Anusham Rubber Industries Private Limited

Manufacturer

🇮🇳 India·Intertek Medical Notified Body AB

Koios Medical Inc.

Manufacturer

🇺🇸 United States·Intertek Medical Notified Body AB

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor Ablation System, Mara Water vapor Probe, Mara Console

ACE Direct Total Iron-Binding Capacity (TIBC) Reagent

FDA registration

ALFA WASSERMANN·3 products·🇺🇸 United States

ABX PENTRA AST CP

FDA registration

HORIBA ABX SAS·3 products·🇫🇷 France

Prolex Legionella pneumophila Serogroup 5 Latex Reagent

FDA UDI

PRO-LAB, INCORPORATED·10628429001797·Each dropper bottle contains 2.7 ml of latex re...

Vision 2

FDA UDI

PRO-LAB, INCORPORATED·00817978020813·Salmonella O:1

Vision 2

FDA UDI

PRO-LAB, INCORPORATED·00817978025344·E. coli O 126: K 71

Prolex Legionella pneumophila Serogroup 14 Latex Reagent

FDA UDI

PRO-LAB, INCORPORATED·10628429002084·Each dropper bottle contains 2.7 ml of latex re...

Electro Lavage

FDA UDI

MECTRA LABS, INC.·00817984010587·Electro Lavage Needle Dual Spike

Filter

FDA UDI

MECTRA LABS, INC.·00817984011065·High Flow