Technomed Europe

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
12
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3131-2024Class IINEUROSIGN Disposable Stimulating Dissector, REF 5888-00July 25, 2024
Z-1737-2022Class IIDisposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles perAugust 9, 2022
Z-0465-2022Class IIDisposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-CDecember 8, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle EMarch 15, 2026
K241045Disposable Subdermal Needle Electrode, CorkscrewDecember 11, 2024
K130136DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRJuly 19, 2013
K121257LARYNGEAL ELECTRODEAugust 28, 2012
K110422SURGICAL STIMULATORSMay 26, 2011
K073532DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODESMay 1, 2008
K072016CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLEOctober 19, 2007
K063729DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00August 21, 2007
K062437DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELEDFebruary 16, 2007
K050325DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBEMay 5, 2005
K042375SMK, CX, CXE, RCNOctober 26, 2004
K990015ELECTRODE NEEDLESMay 27, 1999