Company ยท US
Axelgaard Mfg. Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2014. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 2014 | K132422 | PALS PLATINUM NEUROSTIMULATION ELECTRODES Axelgaard Mfg. Co., Ltd. | GXY |
| Jul 17, 2013 | K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES Axelgaard Mfg. Co., Ltd. | GXY |
| Jun 18, 2008 | K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D Axelgaard Mfg. Co., Ltd. | EGJ |
| Aug 22, 2002 | K013532 | ULTRASTIM KIT Axelgaard Mfg. Co., Ltd. | GZJ |
| Jun 16, 2000 | K000947 | ULTRASTIM ELECTRODE, MODEL US4040 Axelgaard Mfg. Co., Ltd. | GXY |
| Apr 13, 2000 | K000206 | PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 Axelgaard Mfg. Co., Ltd. | DRX |
| Dec 18, 1998 | K983741 | EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 Axelgaard Mfg. Co., Ltd. | GXY |
| May 9, 1997 | K970426 | VALUETRODE Axelgaard Mfg. Co., Ltd. | GXY |
| Jan 28, 1988 | K874469 | TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) Axelgaard Mfg. Co., Ltd. | GXY |
| Sep 22, 1987 | K872976 | TENS PALS PLUS Axelgaard Mfg. Co., Ltd. | GXY |
| Jun 18, 1985 | K852267 | ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES Axelgaard Mfg. Co., Ltd. | GXY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||