Spatz FGIA Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS

Handling belt - medium

Basic UDI-DI

EU MDD · Eu Md Class 1 ·NRS Healthcare·1 device

Profiling Bed

Basic UDI-DI

EU MDD · Eu Md Class 1 ·NRS Healthcare·1 device

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs, LIAISON® XL Murex Anti-HBs Verifier

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) Leads, Extensions and Adapters

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS) Leads, Extensions and Adapters

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS) External Pulse Generator (EPG), Infinity DBS EPG Base

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS ACCESSORIES; EXTENSION ;NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY; KINETRA FAMILY, DBS SCREEING SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTEGE PROGRAMMER, PATIENT PROGRAMMER (MRI)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS System - Lead and Extension

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBs Immunoassay

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DEEP BRAIN STIMULATION (DBS)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA THERAPY FOR DBS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE 2000 Anti-HBs