Company ยท US
Dantec Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1996. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 6 |
| GWF | Stimulator, Electrical, Evoked Response | 5 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 |
| DXT | Injector And Syringe, Angiographic | 1 |
| EXY | Uroflowmeter | 1 |
| FEN | Device, Cystometric, Hydraulic | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 |
| GXE | Leukotome | 1 |
| GXY | Electrode, Cutaneous | 1 |
| GXZ | Electrode, Needle | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 1996 | K960503 | DANTEC DUET Dantec Medical, Inc. | FEN |
| Mar 25, 1996 | K950314 | DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) Dantec Medical, Inc. | GXZ |
| Nov 21, 1995 | K953999 | DANTEC DA CAPO Dantec Medical, Inc. | EXY |
| Jun 19, 1995 | K926363 | MULTI-DOP S Dantec Medical, Inc. | IYO |
| Jun 14, 1995 | K931801 | MULTI-DOP X Dantec Medical, Inc. | IYO |
| Feb 3, 1995 | K930458 | MULTI-DOP L Dantec Medical, Inc. | IYN |
| Oct 4, 1994 | K932059 | NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE Dantec Medical, Inc. | IKT |
| Sep 26, 1994 | K934580 | DANTEC 13R45 BAR ELECTRODE Dantec Medical, Inc. | GXY |
| Mar 30, 1994 | K931966 | DANTEC DISPOSABLE CONCENTRIC NEEDLE Dantec Medical, Inc. | IKT |
| Nov 9, 1993 | K931923 | DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) Dantec Medical, Inc. | GWF |
| Aug 31, 1993 | K926516 | DANTEC MAGNETIC STIMULATOR MAGPRO Dantec Medical, Inc. | GWF |
| Mar 10, 1993 | K924127 | DANTEC EVOLUTION Dantec Medical, Inc. | GWF |
| Feb 22, 1993 | K923117 | CAVERNOSOMETRY MODULE FOR MENUET Dantec Medical, Inc. | DXT |
| Dec 8, 1992 | K915741 | DISPOSABLE MONOPLAR MEDDLE ELECTRODES Dantec Medical, Inc. | GXE |
| Jan 30, 1992 | K913957 | DANTEC COUNTERPOINT MK2(TM) Dantec Medical, Inc. | GWJ |
| Jan 23, 1992 | K913169 | DANTEC UD 5500 MK2 Dantec Medical, Inc. | FAP |
| Jan 7, 1992 | K914891 | PULLER OPTION FOR ETUDE(TM) Dantec Medical, Inc. | FAP |
| Dec 9, 1991 | K912701 | DANTEC MENUET Dantec Medical, Inc. | FAP |
| Sep 30, 1991 | K911229 | PHOENIX DIGITAL EEG SYSTEM Dantec Medical, Inc. | GWQ |
| Sep 23, 1991 | K913323 | ETUDE (MODEL NUMBERS 24A05 & 24A06) Dantec Medical, Inc. | FAP |
| May 14, 1991 | K902607 | DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2) Dantec Medical, Inc. | GWF |
| Oct 26, 1990 | K901494 | ETUDE, URODYNAMIC INVESTIGATION SYSTEM Dantec Medical, Inc. | FAP |
| Jun 18, 1990 | K896874 | DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12 Dantec Medical, Inc. | IKT |
| May 3, 1990 | K896575 | DANTEC MENUET Dantec Medical, Inc. | FAP |
| Feb 16, 1990 | K896567 | CANTATA EMG/EVOKED RESPONSE SYSTEM Dantec Medical, Inc. | GWF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||