Company ยท TW
Monitex Industrial Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2017. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | 9 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 27, 2017 | K161855 | LED Curing Light Monitex Industrial Co., Ltd., TW | EBZ |
| Apr 7, 2017 | K152192 | LED Curing Light Monitex Industrial Co., Ltd., TW | EBZ |
| Jun 28, 2016 | K153078 | LED Curing Light GT-2000 Monitex Industrial Co., Ltd., TW | EBZ |
| Aug 24, 2015 | K150205 | LED Curing Light Monitex Industrial Co., Ltd., TW | EBZ |
| Oct 7, 2014 | K133040 | LED CURING LIGHT Monitex Industrial Co., Ltd., TW | EBZ |
| Sep 18, 2009 | K091887 | LED CURING LIGHT, MODEL GT-1500 Monitex Industrial Co., Ltd., TW | EBZ |
| Mar 3, 2008 | K080035 | LED CURING LIGHT Monitex Industrial Co., Ltd., TW | EBZ |
| Apr 21, 2006 | K060646 | BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 Monitex Industrial Co., Ltd., TW | EBZ |
| May 25, 2005 | K051203 | BLUELEX Monitex Industrial Co., Ltd., TW | EBZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||