TC SERIES (TRANSPORT)

FDA 510(k)

FDA Class 1 ·Physical Medicine

TC SERIES

FDA 510(k)

FDA Class 1 ·Physical Medicine

TC SERIES (RECLINER)

FDA 510(k)

FDA Class 1 ·Physical Medicine

TC SERIES (TILT RECLINER)

FDA 510(k)

FDA Class 1 ·Physical Medicine

TC SERIES (WIDE)

FDA 510(k)

FDA Class 1 ·Physical Medicine

Brightwake Limited

Manufacturer

102 Basic UDI-DIs·113 Devices·3 Importers·SGS Belgium NV, Kiwa Belgelendirme Hizmetleri A.Ş., SGS Belgium NV, and SGS Belgium NV

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ISOMED REFILL KIT/BULK REFILL KIT/ISOMED CAP KIT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

ORTHOSOURCE

FDA UDI

ORTHOSOURCE·D911557617C0·Blue Etch 15 gm syringe

ORTHOSOURCE

FDA UDI

ORTHOSOURCE·D911557418C0·Red Etch 15 gm syringe

ORTHOSOURCE

FDA UDI

ORTHOSOURCE·D911557618C0·Green Etch 15 gm syringe

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDX 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 Antibody Assay, C-Kit

FDA Pre-Market Approval

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

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Abbott RealTime IDH1 Assay

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP

SARIS AND THINGS, INC.

FDA registration

SARIS AND THINGS, INC.·1 product·🇺🇸 United States

Medline Blood And Urine Collection Kit (Excludes Hiv Testing)

FDA registration

MEDLINE INDUSTRIES, LP - Laredo·1 product·🇺🇸 United States