Company ยท US
Cytophil, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2015. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 6, 2015 | K150400 | Renu Gel Cytophil, Inc. | MIX |
| Feb 22, 2013 | K121795 | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT Cytophil, Inc. | MIX |
| Dec 27, 2010 | K102937 | OSTEOPHIL BETA-TCP Cytophil, Inc. | MQV |
| Apr 22, 2010 | K093871 | PERIOPHIL B-TCP Cytophil, Inc. | LYC |
| Dec 18, 2009 | K092788 | PERIOPHIL BIPHASIC Cytophil, Inc. | LYC |
| Jan 5, 2009 | K081816 | VOCALIS AND VOCALIS SM Cytophil, Inc. | MIX |
| Jan 5, 2009 | K081815 | VOCALIS GEL Cytophil, Inc. | MIX |
| Jan 18, 2008 | K072219 | CYTOPHIL TISSUE MARKER Cytophil, Inc. | NEU |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2012 | Cytophil, Inc Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc.
Model # 03003-01 Periobase Biphasic: Periobase, Synthetic Biphasic Dental Bone Biphasic Granules, 0.5 cc Terminated |
LYC | K092788 |