Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LEADS SERVICE KIT & LEADS WRENCH KIT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD, SERVICE KIT PACEMAKER REPAIR KIT

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·SenSight™ Directional Lead Kit, SenSight™ Extension Kit

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·URO VYSION BLADDER CANCER KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Self-Cath Closed System

FDA registration

Coloplast Manufacturing US, LLC.·1 product·🇺🇸 United States

ISOMEDIX OPERATIONS INC

FDA registration

ISOMEDIX OPERATIONS INC·1 product·🇺🇸 United States

Urethral Kit

FDA registration

C.R. BARD, INC.·1 product·🇺🇸 United States

(confidential) Urethral Catheterization Tray (w/ or w/o Catheter)

FDA registration

CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

ST AIA-PACK AFP

FDA registration

TOSOH AIA, INC.·2 products·🇯🇵 Japan

Urethral Kit

FDA registration

C.R. BARD, INC.·1 product·🇺🇸 United States

Multi-Drug test panel

FDA registration

Diagnostic Automation/ Cortez Diagnostics Inc,.·1 product·🇺🇸 United States

BD Durasafe Combined Anesthesia Kit

FDA registration

CAREFUSION 2200, INC.·2 products·🇺🇸 United States

Cath Kit

FDA registration

Medline Industries, LP - Mexicali (MXC)·1 product·🇲🇽 Mexico

Self-Cath Closed System

FDA registration

SUZHOU PROSTERI MEDICAL TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

Cath Kit

FDA registration

PRODUCTOS MEDLINE S.A. DE C.V.·1 product·🇲🇽 Mexico

Introducer Cannula™ IC-155

FDA registration

ORTHOPEDIC SCIENCES, INC·1 product·🇺🇸 United States