85 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Microlab AT, part numbers 135001, 135001OOC, 135002, 135003, 135005, 135006, 135006R, 135007, 135008, 135016, 135028, 135029, 936400, 936400BLU. Microlab AT+ and Microlab AT+2, part numbers 142000, 142001, 142001R, 142002, 142003, 142005, 142006, 142006R, 142007, 142008, 142009, 142015, 142017, 142035, 142036
FDA Recall
Terminated
·Hamilton Co·Product code JTC·December 13, 2005
Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
FDA Recall
Terminated
·Kalila Medical·Product code DYB·December 14, 2017
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
FDA Recall
Terminated
·Kalila Medical·Product code DYB·December 14, 2017
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode
FDA Enforcement
Class II
·Terminated·Cyberonics, Inc·August 23, 2017
Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·March 14, 2018
ReWalk Personal 6.0. Catalog number: 50-20-0004.
FDA Recall
Terminated
·Argo Medical Technologies Ltd Matambuilding 30p.O.Box·Product code PHL·August 14, 2017
IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
FDA Recall
Terminated
·Deerfield Imaging·Product code HBL·August 14, 2017
Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.
FDA Enforcement
Class II
·Terminated·Alcon Research, Ltd.·July 8, 2015
TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
FDA Recall
Terminated
·Mindray DS USA, Inc. dba Mindray North America·Product code MSX·July 14, 2017
Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Dr Bragg Vein Tray - RX, part number 007912-8
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.
FDA Recall
Terminated
·Shippert Medical Technologies·Product code N/A·June 1, 2017
Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.
FDA Recall
Terminated
·Shippert Medical Technologies·Product code KYZ·June 1, 2017
Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and liposuction.
FDA Recall
Terminated
·Shippert Medical Technologies·Product code N/A·June 1, 2017
Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposuction.
FDA Recall
Terminated
·Shippert Medical Technologies·Product code N/A·June 1, 2017
Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction.
FDA Recall
Terminated
·Shippert Medical Technologies·Product code KYZ·June 1, 2017
Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer and liposuction.
FDA Recall
Terminated
·Shippert Medical Technologies·Product code N/A·June 1, 2017
Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.
FDA Recall
Terminated
·Shippert Medical Technologies·Product code N/A·June 1, 2017