60 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·February 28, 2024
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.
FDA Enforcement
Class II
·Ongoing·Neilmed Pharmaceuticals Inc·February 12, 2025
Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
FDA Enforcement
Class II
·Terminated·Iba Dosimetry·June 14, 2017
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
FDA Enforcement
Class II
·Terminated·Iba Dosimetry Gmbh·December 18, 2013
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
FDA Enforcement
Class II
·Terminated·Iba Dosimetry Gmbh·March 4, 2015
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
FDA Enforcement
Class II
·Terminated·Iba Dosimetry Gmbh·January 27, 2016
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
FDA Enforcement
Class II
·Terminated·Iba Dosimetry Gmbh·November 12, 2014
myQA iON; Article Number: MQ10-000;
FDA Enforcement
Class II
·Ongoing·IBA Dosimetry GmbH·May 7, 2025
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
FDA Enforcement
Class II
·Terminated·New Era Orthopaedics, LLc·August 15, 2018
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