510(k) K954340 ยท HQC Unit, Phacofragmentation
STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
| Applicant | Storz, St. Louis MO, US |
| Decision | Substantially Equivalent, Dec 14, 1995 |
| Received | Sep 18, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954340
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb MicroFlow 30 Phaco Needle, Model DP8230S, 6 pouches/box. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in the package is Terminated |
HQC | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb MicroFlow 45 Phaco Needle, Model DP8245S, 6 pouches/box. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in the package is Terminated |
HQC | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb MicroFlow Plus 30 Phaco Needle, Model DP8330S, 6 pouches/box. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in the packag Terminated |
HQC | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb MicroFlow 2.2 30 Phaco Needle, Model DP8730S, 6 pouches/box. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in the packag Terminated |
HQC | None listed |
| Oct 15, 2003 | Bausch & Lomb Incorporated Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box. Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.