Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA

K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE PEDIATRIC ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE, MODEL KDP-60A

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE PEDIATRIC ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602

FDA 510(k)

FDA Class 3 ·Cardiovascular

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

Replacer, Ureteral

FDA classification

FDA Class 3 ·Replacer, Ureteral

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Claudin 18

FDA Pre-Market Approval

FDA Class 3 ·VENTANA CLDN18 (43-14A) RxDx Assay

Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP142) Assay

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP263) ASSAY