Company ยท US
Entific Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2004. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LXB | Hearing Aid, Bone Conduction | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2004 | K042017 | BAHA DIVINO Entific Medical Systems, Inc. | LXB |
| Aug 30, 2002 | K021837 | BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) Entific Medical Systems, Inc. | LXB |
| Jul 23, 2001 | K011438 | BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. Entific Medical Systems, Inc. | LXB |
| Oct 17, 2000 | K002913 | HEADBAND FOR BAHA Entific Medical Systems, Inc. | LXB |
| Nov 24, 1999 | K992872 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II Entific Medical Systems, Inc. | LXB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||