191 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNL·November 16, 2005
BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne. Nicolet Biomedical, Inc.
FDA Recall
Terminated
·Nicolet Biomedical Div of Viasys Healthcare·Product code GWQ·July 17, 2007
SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic device designed for single use only.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Surgical, Inc.·May 24, 2017
Easy Diagnost DSI is a Easy Diagnost Digital Spot Imaging system. It has a capability to create digital images from an analog system. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXR·January 4, 2008
Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNJ·November 16, 2005
Easy Diagnost Eleva Universal Fluoroscopic applications
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·December 11, 2013
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·July 3, 2013
sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
FDA Enforcement
Class II
·Terminated·SenTec AG·November 9, 2022
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·June 27, 2012
SPI EASY Abutment. Endosseous dental implant abutment.
FDA Recall
Terminated
·Thommen Medical, AG Hauptstrasse, 87 Waldenburg Switzerland·Product code DZE·April 19, 2007
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
FDA Enforcement
Class II
·Terminated·Kinsman Enterprises Inc·October 27, 2021
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 11, 2013
OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label states: ''Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by: ICC, Amherst, NY 14228
FDA Recall
Terminated
·International Chemical Inc.·Product code LCX·October 7, 2004
Easy Diagnost Digital
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male and female patients
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 30, 2016
Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.
FDA Recall
Terminated
·Silver Star Brands·Product code IOR·October 10, 2014
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·February 13, 2013
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·June 18, 2014
Philips Easy Diagnost Eleva
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code KPR·July 23, 2007
Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code KPR·January 21, 2009