Cytophil, Inc
East Troy, WI, US
Cytophil, Inc appears in FDA device records in East Troy, WI. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Cytophil, Inc between 2008 and 2015. The busiest year on record is 2009, with 3. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 2 |
| 2013 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K150400 | Renu Gel | MIX | Substantially Equivalent | |
| K121795 | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT | MIX | Substantially Equivalent | |
| K102937 | OSTEOPHIL BETA-TCP | MQV | Substantially Equivalent | |
| K093871 | PERIOPHIL B-TCP | LYC | Substantially Equivalent | |
| K092788 | PERIOPHIL BIPHASIC | LYC | Substantially Equivalent | |
| K081816 | VOCALIS AND VOCALIS SM | MIX | Substantially Equivalent | |
| K081815 | VOCALIS GEL | MIX | Substantially Equivalent | |
| K072219 | CYTOPHIL TISSUE MARKER | NEU | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007225376 | 3007225376 | Cytophil, Inc | 2485 Corporate Circle, Unit 2, East Troy, WI 53120 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1012-2012 | 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. Model #03002-01: Periobone Biphasic, Synthetic HA/TCP Dental Bone Graft Biphasic Granules, 0.5 cc. Periophil Biphasic (synthetic grafting material) is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. Cytophil, Inc., 2485 Corporate Circle, Suite 2, East Roy, WI 53120. | Cytophil Corporation is recalling Periophil Biphasic Periophil Biphasic, Periobase Biphasic, and Periobone Biphasic because devices were inadvertently shipped after receiving an inadequate dose of radiation and this product may not be sterile. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Cytophil, Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain