265 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Spirit One A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016
Spirit One A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016
Hospira Power cord use on Symbiq One-Channel infuser and Symbiq Two-Channel infuser. Power cord part number: HSP3306-E07. Used on List No. 16026 - Symbiq One Channel infuser; List No. 16027 - Symbiq Two-Channel infuser
FDA Recall
Terminated
·Hospira Inc·Product code FRN·October 27, 2010
Powered stretcher chair used during facial and eye surgeries. One chair per package.
FDA Enforcement
Class II
·Terminated·TransMotion Medical Inc·January 28, 2015
Spirit One A-C Powered Hospital Bed
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FNL·July 2, 2015
Spirit One A-C Powered Hospital Bed
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FNL·July 2, 2015
CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·August 28, 2013
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·October 2, 2013
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268840 used with First Step All-In-One Canadian French Models 227500-09 and 227500, First Step All-In-One English Model 227500, Therakair Visio Models M8259978 and M6257763 pump only, and Proficare - Canada Model M8259988
FDA Recall
Terminated
·KCI USA, Inc.·Product code IKY·November 4, 2009
Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·August 19, 2015
Powered stretcher chair used during facial and eye surgeries. One chair per package.
FDA Recall
Terminated
·TransMotion Medical Inc·Product code GBB·November 14, 2014
Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 25, 2015
CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.
FDA Recall
Terminated
·Invacare Corporation·Product code INO·June 18, 2013
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
FDA Enforcement
Class I
·Terminated·Hospira Inc.·November 5, 2014
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
FDA Recall
Terminated
·Invacare Corporation·Product code ITI·June 4, 2013
Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
FDA Recall
Terminated
·Invacare Corporation·Product code ITI·February 2, 2015
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
FDA Enforcement
Class I
·Terminated·Hospira Inc.·November 5, 2014
PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·July 15, 2020