392 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Recall
Terminated
·Arrow International Inc·Product code FOZ·August 27, 2015
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
Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE
FDA Recall
Terminated
·Covidien LLC·Product code FSY·April 16, 2015
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
Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds
FDA Recall
Terminated
·Covidien LLC·Product code NAD·March 3, 2017
Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
FDA Recall
Terminated
·Covidien LLC·Product code NAD·March 3, 2017
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 Recall
Terminated
·Covidien, LLC·Product code EOX·June 6, 2016
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 Recall
Terminated
·Covidien, LLC·Product code EOX·June 6, 2016
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
FDA Recall
Terminated
·Covidien LLC·Product code MGQ·March 3, 2017
Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
FDA Recall
Terminated
·Covidien LLC·Product code NAD·March 3, 2017
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
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
FDA Recall
Terminated
·Medtronic·Product code FEI·October 4, 2016
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