13 results
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13ms
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Sources: EU EUDAMED, US FDA
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·August 31, 2016
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·December 18, 2019
McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
FDA Enforcement
Class II
·Terminated·Cypress Medical Products LLC·October 24, 2018
Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
FDA Enforcement
Class II
·Terminated·Arjo, Inc. dba ArjoHuntleigh·August 14, 2013
Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
FDA Enforcement
Class II
·Terminated·Arjo, Inc. dba ArjoHuntleigh·August 14, 2013
3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.
FDA Enforcement
Class II
·Terminated·NeoCoil, LLC·August 10, 2016
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·January 15, 2014
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·January 15, 2014
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·January 15, 2014
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·January 15, 2014
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·January 15, 2014
Centurion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT DM380 DAILY LVAD KIT MORRISTOWN MEDICAL DM405A ADVOCATE CHRIST DAILY WET KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT DM545 U OF U LVAD SENSITIVE SKIN DRESSING SYST DM550 VAD DRIVELINE MANAGEMENT TRAY DM555 LVAD MULTI-DAY DRIVELINE MGMT SIZE M/L DM565 LVAD DRESSING SYSTEM DM575 LVAD MULTI-DAY DRIVELINE MGMT SIZE S DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM690 VAD DRIVELINE MANAGEMENT BUNDLE DM710 VAD DAILY DRESSING CHANGE KIT DM720 DAILY LVAD MAINTENANCE KIT DM765 DAILY DRIVELINE MANAGEMENT SYSTEM DM770 WEEKLY DRIVELINE MANAGEMENT SYSTEM DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM805 DAILY LVAD DRIVELINE MANAGEMENT SYSTEM DM870 DAILY MAINTENANCE SYSTEM LVAD DM920 GAUZE DRIVELINE MANAGEMENT KIT DM925 SORBAVIEW DRIVELINE MANAGEMENT KIT DM935 DAILY DRIVELINE MANAGEMENT SYSTEM DM950 HIGH DRAINAGE LVAD TRAY
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·February 12, 2020
Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT DM380 DAILY LVAD KIT MORRISTOWN MEDICAL DM405A ADVOCATE CHRIST DAILY WET KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT DM545 U OF U LVAD SENSITIVE SKIN DRESSING SYST DM550 VAD DRIVELINE MANAGEMENT TRAY DM555 LVAD MULTI-DAY DRIVELINE MGMT SIZE M/L DM565 LVAD DRESSING SYSTEM DM575 LVAD MULTI-DAY DRIVELINE MGMT SIZE S DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM690 VAD DRIVELINE MANAGEMENT BUNDLE DM710 VAD DAILY DRESSING CHANGE KIT DM720 DAILY LVAD MAINTENANCE KIT DM765 DAILY DRIVELINE MANAGEMENT SYSTEM DM770 WEEKLY DRIVELINE MANAGEMENT SYSTEM DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM805 DAILY LVAD DRIVELINE MANAGEMENT SYSTEM DM870 DAILY MAINTENANCE SYSTEM LVAD DM920 GAUZE DRIVELINE MANAGEMENT KIT DM925 SORBAVIEW DRIVELINE MANAGEMENT KIT DM935 DAILY DRIVELINE MANAGEMENT SYSTEM DM950 HIGH DRAINAGE LVAD TRAY
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·February 12, 2020