77 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs, indoors and outdoors.
FDA Recall
Terminated
·ThyssenKrupp Access Corp·Product code ILK·August 6, 2012
The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.
FDA Recall
Terminated
·Savaria Concord Lifts, Inc.·Product code ILK·April 12, 2017
Powered Mobility Offers Versatility (MV)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code ILK·June 27, 2012
Omega Incline Platform Lift
FDA Recall
Terminated
·Savaria Concord Lifts, Inc.·Product code ILK·April 12, 2017
Powered Mobility Offers Versatility (MV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code ILK·June 27, 2012
Powered Mobility Offers Versatility (MV)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code ILK·June 27, 2012
Powered Mobility Offers Versatility (MV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code ILK·June 27, 2012
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
FDA Enforcement
Class II
·Terminated·Animas Corporation·November 5, 2014
JUDKINS PACK
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·March 24, 2021
Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe Scientific.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CJE·February 7, 2008
Liquid Alk Phos Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-L. In vitro diagnostic.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CJE·June 9, 2006
Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Sold by Pointe Scientific.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CJE·February 7, 2008
Liquid Alk Phos R1 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R1. In vitro diagnostic.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CJE·June 9, 2006
Liquid Alk Phos R2 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R2. In vitro diagnostic.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CJE·June 9, 2006
Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic, Sold by Pointe Scientific
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CJE·February 7, 2008
Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
FDA Recall
Terminated
·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010
Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
FDA Enforcement
Class I
·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
FDA Enforcement
Class I
·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·September 23, 2020
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.
FDA Recall
Terminated
·Brasseler USA I Lp·Product code GFF·October 18, 2019