510(k) K041998 ยท HQC Unit, Phacofragmentation
PHACO CHOP NEEDLES
| Applicant | Bausch & Lomb, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Aug 16, 2004 |
| Received | Jul 26, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041998
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Thin Tip 30 Phaco Needle, Model DP8430S, 6 pouches/box. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in the package is u Terminated |
HQC | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Thin Tip 30 angled Phaco Needle, Model DP8430AS, 6 pouches/box. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in the pac Terminated |
HQC | None listed |
| Sep 16, 2008 | Bausch & Lomb Inc Bausch & Lomb Millennium Phacoemulsification Needles, Needle Tapered Hub 15 Degree, REF DP8115, 6 needles per pouch, nonsterile. Terminated |
NKX | None listed |
| Sep 16, 2008 | Bausch & Lomb Inc Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 30 Degree, REF DP8130, 6 needles per pouch, nonsterile. Terminated |
NKX | None listed |
| Sep 16, 2008 | Bausch & Lomb Inc Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 45 Degree, REF DP8145, 6 needles per pouch, nonsterile. Terminated |
NKX | None listed |
| Sep 16, 2008 | Bausch & Lomb Inc Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 15 Degree, REF DP8415, 6 needles per pouch, nonsterile. Terminated |
NKX | None listed |
| Sep 16, 2008 | Bausch & Lomb Inc Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 30 Degree, REF DP8430, 6 needles per pouch, nonsterile. Terminated |
NKX | None listed |
| Sep 16, 2008 | Bausch & Lomb Inc Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip Angled 30 Degree, REF DP8430A, 6 needles per pouch, nonsterile. Terminated |
NKX | None listed |
| Sep 16, 2008 | Bausch & Lomb Inc Bausch & Lomb Millenium Phacoemulsification Needles, Needle Microflow 2.2 30 Degree, REF DP8730, 6 needles per pouch, nonsterile. Terminated |
NKX | None listed |
| Sep 16, 2008 | Bausch & Lomb Inc Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 15 Degree, REF MVS 1600A, 6 needles per pouch, nonsterile. Terminated |
NKX | None listed |
| Sep 16, 2008 | Bausch & Lomb Inc Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 60 Degree, REF MVS1601A, 6 needles per pouch, nonsterile. Terminated |
NKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.