140 results
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Sources: EU EUDAMED, US FDA
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740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code MHX·June 24, 2008
HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·March 12, 2014
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 20, 2017
Alcon Custom-Pak, part #4917-54, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code HNN·December 22, 2006
PremierEdge MICROSURGICAL KNIFE, 45 DEGREES STAB KNIFE, REF/Item Code: PE 3045, OASIS Glendora, CA 91741
FDA Recall
Terminated
·Oasis Medical Inc·Product code HNN·July 18, 2007
PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife, Item Code/REF: PE 3830; OASIS Glendora, CA 91741
FDA Recall
Terminated
·Oasis Medical Inc·Product code HNN·July 18, 2007
PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife, Item Code/ REF: PE 3128 , OASIS Glendora, CA 91741
FDA Recall
Terminated
·Oasis Medical Inc·Product code HNN·July 18, 2007
PremierEdge MICROSURGICAL KNIFE , 2.85mm Thin Slit Knife, Item Code/REF: PE4828-TL; OASIS Glendora, CA 91741
FDA Recall
Terminated
·Oasis Medical Inc·Product code HNN·July 18, 2007
BD Beaver Mini-Blade, Blade Mini Orthopedic 1.31 in, Catalog Number: 376100
FDA Recall
Terminated
·Becton Dickinson and Company·Product code HNN·December 26, 2006
Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
FDA Recall
Terminated
·Invacare Corporation·Product code INN·June 25, 2014
Stylus Brand Angled Knife 52-2931, Slit Knife, double bevel, angled, full handle, 3.0mm 52-3231, Slit Knife, double bevel, angled, full handle, 3.2mm
FDA Recall
Terminated
·Surgical Specialties Puerto Rico, Inc. Road·Product code HNN·March 3, 2004
Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INN·April 2, 2015
Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INN·April 2, 2015
Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INN·April 2, 2015
Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
FDA Recall
Terminated
·Bausch & Lomb Inc Irb·Product code HNN·July 11, 2016
Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
FDA Recall
Terminated
·Beaver Visitec·Product code HNN·March 12, 2019
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 Recall
Terminated
·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017
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 they are available to surgeons for use in procedures.
FDA Recall
Terminated
·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017
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 therapeutic use and they are available to surgeons for use in procedures.
FDA Recall
Terminated
·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017