28 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.
FDA Recall
Terminated
·Omnyx Llc·Product code OTU·October 1, 2013
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
Bloom DTU-215-B Programmable Stimulator
FDA Recall
Terminated
·Fischer Imaging Corporation·Product code JOQ·January 13, 2005
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-NT-U
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·November 25, 2002
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC-NT-U
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·November 25, 2002
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
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 Recall
Terminated
·Arjo, Inc. dba ArjoHuntleigh·Product code FNL·November 16, 2012
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 Recall
Terminated
·Arjo, Inc. dba ArjoHuntleigh·Product code FNL·November 16, 2012
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
FDA Recall
Terminated
·Baxter Healthcare Corp·Product code KPE·September 16, 2014
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
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
FDA Recall
Terminated
·Baxter Healthcare Corp·Product code KPE·September 16, 2014
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
Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Medtronic Ideal MAXPAC Total System
FDA Recall
Terminated
·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009
Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
FDA Recall
Terminated
·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009
Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
FDA Recall
Terminated
·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009