164 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Ellipsys Power Controller
FDA UDI
AVENU MEDICAL, INC.·B357AMI1000·
Ellipsys Power Controller
FDA UDI
AVENU MEDICAL, INC.·B357AMI1001·The Ellipsys® Power Controller is the reusable ...
Ellipsys Vascular Access System
FDA UDI
AVENU MEDICAL, INC.·B357AMI6005·The Ellipsys® Vascular Access System is indicat...
Ellipsys Vascular Access System
FDA UDI
AVENU MEDICAL, INC.·00763000496982·The Ellipsys® Vascular Access System is indicat...
Ellipsys Vascular Access System
FDA UDI
AVENU MEDICAL, INC.·00763000496975·The Ellipsys® Vascular Access System is indicat...
Ellipsys Power Controller
FDA UDI
AVENU MEDICAL, INC.·00763000574710·The Ellipsys® Power Controller is the reusable ...
Ellipsys Vascular Access System
FDA UDI
AVENU MEDICAL, INC.·B357AMI6050·The Ellipsys Vascular Access System is indicate...
Ellipsys Power Controller
FDA UDI
AVENU MEDICAL, INC.·00763000478193·The Ellipsys® Power Controller is the reusable ...
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
FDA Enforcement
Class I
·Terminated·Nephros Inc·December 25, 2013
Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·July 3, 2013
ETHIBOND* EXCEL
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·July 16, 2024
ETHIBOND* EXCEL
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·July 16, 2024
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·January 10, 2024
GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE Medical Systems, Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee, WI 53223 USA.
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007
GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA.
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007
HISTOFREEZER FREEZING DEVICE
FDA Adverse Event
Malfunction
·STC TECHNOLOGIES, INC.·Product code KSE·March 10, 1999
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Recall
Terminated
·Cardio Medical Products·Product code LDD·April 26, 2013
Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Plymouth, Minnesota 55441-5443 USA.
FDA Recall
Terminated
·Nonin Medical, Inc·Product code MUD·October 23, 2009
Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Pediatric Bone Marrow Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009