510(k) K063331 ยท HQC Unit, Phacofragmentation
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
| Applicant | Bausch & Lomb, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 19, 2006 |
| Received | Nov 3, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K063331
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Model BL5110, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench containe Terminated |
HQE | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Vacuum Phaco Pack, Model BL5111, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in the Terminated |
HQE | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Model BL5112, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench co Terminated |
HQE | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Premium AFS Phaco Pack, Model BL5120, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained i Terminated |
HQE | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Basic AFS Phaco Pack, Model BL5121, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in Terminated |
HQE | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Needle, Model BL5113, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic Terminated |
HQE | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Angled Needle, Model BL5113A, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The Terminated |
HQE | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Model BL5114, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic Terminated |
HQE | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Angled Needle, Model BL5114A, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The Terminated |
HQE | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Needle, Model BL5123, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The pla Terminated |
HQE | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Angled Needle, Model BL5123A, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. Terminated |
HQE | None listed |
| May 26, 2010 | Bausch & Lomb Inc Bausch & Lomb Stellaris Vision Enhancement System. Terminated |
NFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.