Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE PRIME, PRIMEADVANCED, RESTORE RECHARGEABLE, RESTORE ADVANCED AND RECHARGEABLE MODELS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK LEAD FAMILY

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·C-KIT PHARMDX

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

FDA Pre-Market Approval

FDA Class 3 ·UROVYSION BLADDER CANCER KIT

ForSure iFOB Test Set

FDA UDI

SYNTRON BIORESEARCH, INC.·00748349000021·ForSure iFOB test set Contains: 1 test device 1...

Omnipod DASH Starter Kit

FDA UDI

INSULET CORPORATION·10385082000009·Starter Kit (PDM) mg/dL - Dash, english

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ACTIVA PARKINSON CONTROL THERAPY

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·C-KIT PHARMDX

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