82 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·July 27, 2016
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
FDA Enforcement
Class II
·Terminated·Arrow International Inc·October 7, 2015
Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
FDA Enforcement
Class II
·Terminated·Covidien, LLC·July 13, 2016
Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.
FDA Enforcement
Class II
·Terminated·Covidien, LLC·July 13, 2016
Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.
FDA Enforcement
Class II
·Terminated·Covidien LP·February 14, 2018
Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures
FDA Enforcement
Class II
·Terminated·Covidien Medical Products (Shanghai) Manufacturing L.L.C.·March 23, 2016
PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
FDA Enforcement
Class II
·Terminated·Covidien LP (formerly Nellcor Puritan Bennett Inc.)·March 23, 2016