64 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc·December 31, 2014
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQF·November 4, 2014
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQF·November 4, 2014
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc·December 31, 2014
Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 15, 2016
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 15, 2016
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 15, 2016
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQF·November 4, 2014
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
FDA Enforcement
Class II
·Terminated·AGFA Corp.·April 17, 2013
Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with either Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505, 750 and 775 Indicated for hyper- or hypothermic patients or normothermic patients, for whom induced hyper- hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
FDA Recall
Terminated
·Arizant Inc·Product code DWJ·December 17, 2009
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·March 15, 2013
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc·December 31, 2014
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
FDA Enforcement
Class II
·Terminated·PTW-Freiburg·September 2, 2015
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code JEY·May 2, 2016
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code JEY·May 2, 2016
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code JEY·May 2, 2016
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
FDA Recall
Terminated
·PTW NORTH AMERICA CORPORATION·Product code IYE·August 27, 2021