57 results
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7ms
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Sources: EU EUDAMED, US FDA
BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·December 13, 2017
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
FDA Enforcement
Class II
·Ongoing·Ethicon, Inc.·May 18, 2022
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
FDA Enforcement
Class II
·Ongoing·NRT X-RAY A/S·May 15, 2024
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 Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·November 11, 2015
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, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·November 30, 2016
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 they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018
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 therapeutic use and they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018
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 they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018
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 therapeutic use and they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018
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 therapeutic use and they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018
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 use and they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018
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 therapeutic use and they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018
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 therapeutic use and they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018
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 and they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018
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 therapeutic use and they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018
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 they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018
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 therapeutic use and they are available to surgeons for use in procedures.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·March 14, 2018