Company
Bausch & Lomb Inc Irb
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
48recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no th Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 1.8mm x 2.2mm TRAPEZOID ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7603G, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therape Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7601G, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therape Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 1.6MM X 1.8MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7600, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic us Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.9MM (6/BOX), REF/PRODUCT CODE E7587A, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use a Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR (6/BOX), REF/PRODUCT CODE E7575, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 5.2MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7561A, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use an Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use an Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, KNIFE ANGLED BEVELED UP 2.7(6/BOX), REF/PRODUCT CODE E7559A, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use a Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 3.2MM STRAIGHT SLIT KNIFE (6/BOX), REF/PRODUCT CODE E7557, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7556AG, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556ADB, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no thera Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556A, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therape Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.85MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7553A, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7552ADB, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no thera Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no t Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/PRODUCT CODE E7551ADBG, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There i Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7551ADB, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no ther Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.65 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7551A, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use an Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.5 MM SLIT KNIFE BEVEL UP ANGLED GUARDED(6/BOX), REF/PRODUCT CODE E7550AG, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no th Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7550ADB, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no ther Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic u Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 2.2 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7548ADB, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no ther Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7529, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no thera Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therape Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 22.5 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7522, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and th Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they a Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they a Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 15 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7515T, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and the Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510G, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, CRESCENT BLADE BEVELED DN (6/BOX), REF/PRODUCT CODE E7510D, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use an Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT CODE E7510AT, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeut Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic Terminated |
HNN | None listed |
| Mar 3, 2017 | Bausch & Lomb Inc Irb LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only
Product Usage:
The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeu Terminated |
HNN | None listed |
| Sep 19, 2016 | Bausch & Lomb Inc Irb PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Roch Terminated |
LPN | K132216 |
| Jul 11, 2016 | Bausch & Lomb Inc Irb Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599
Product Usage:
Available to surgeons for use in ophthalmic surgical procedures. Terminated |
HNN | None listed |
| Jul 11, 2016 | Bausch & Lomb Inc Irb Laseredge 1.1mm Arrow Knife Angled, REF E7592
Product Usage:
Available to surgeons for use in ophthalmic surgical procedures. Terminated |
HNN | None listed |
| Nov 4, 2015 | Bausch & Lomb Inc Irb BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Terminated |
LPL | K113703 |