Medical Device Manufacturer · NL , Kerkrade

Technomed Europe

12 submissions · 12 cleared · Since 1999

12

Total

12

Cleared

0

Denied

Technomed Europe — FDA 510(k) Submissions

Technomed Europe has submitted 12 FDA 510(k) premarket notifications since 1999, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Needle, Electrode, Needle, Diagnostic Electromyograph, Electrode, Cutaneous, Stimulator, Nerve, Probe, Radiofrequency Lesion . Use the specialty filter in the sidebar to narrow results.

12 devices

1–12 of 12

Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)

K253581 · IKT Electrode, Needle,... · Neurology

Disposable Subdermal Needle Electrode, Corkscrew

K241045 · GXZ Electrode, Needle · Neurology

DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,

K130136 · GXZ Electrode, Needle · Neurology

LARYNGEAL ELECTRODE

K121257 · ETN Stimulator, Nerve · Ear, Nose, Throat

SURGICAL STIMULATORS

K110422 · ETN Stimulator, Nerve · Ear, Nose, Throat

DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES

K073532 · GXY Electrode, Cutaneous · Neurology

CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE

K072016 · GXY Electrode, Cutaneous · Neurology

DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00

K063729 · GXZ Electrode, Needle · Neurology

DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED

K062437 · IKT Electrode, Needle,... · Neurology

DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE

K050325 · GXZ Electrode, Needle · Neurology

SMK, CX, CXE, RCN

K042375 · GXI Probe, Radiofrequency Lesion · Neurology

ELECTRODE NEEDLES

K990015 · IKT Electrode, Needle,... · Neurology