244 results
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9ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3MPDLX-QS, SC900-80WDLX-QSP, SC900-80PDLX-QSP, IH820-3MDLX-AE-333PS, SC90080GDLX-AE-366PA, SC90080GDLX-AE-333PS, IH820-3MDLX-AE-366PS, IH820-3MDLX-AE-333PA, IH820-3MDLX-AE-366PA and SC90080GDLX-AE-366PS
FDA Recall
Terminated
·Invacare Corporation·Product code LLI·September 27, 2006
Unicel DxH 800 Coulter Cellular Analysis System. A quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·April 14, 2011
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code MNT·April 6, 2021
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code MNT·April 6, 2021
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
FDA Enforcement
Class II
·Terminated·Philips Respironics, Inc.·June 2, 2021
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
FDA Enforcement
Class II
·Terminated·Philips Respironics, Inc.·June 2, 2021
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
FDA Enforcement
Class II
·Terminated·Degania Silicone, Ltd.·March 1, 2017
Sara Plus Active Floor Lift
FDA Enforcement
Class I
·Terminated·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·June 1, 2022
BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
FDA Enforcement
Class III
·Terminated·Degania Silicone, Ltd.·March 14, 2018
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code GBX·October 3, 2017
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code GBX·January 31, 2017
Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
FDA Enforcement
Class II
·Terminated·Degania Silicone, Ltd.·August 21, 2019
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
FDA Enforcement
Class II
·Terminated·Degania Silicone, Ltd.·August 21, 2019
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
FDA Enforcement
Class II
·Terminated·Degania Silicone, Ltd.·August 21, 2019
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
FDA Enforcement
Class II
·Terminated·Degania Silicone, Ltd.·August 21, 2019
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
FDA Enforcement
Class II
·Terminated·Degania Silicone, Ltd.·August 21, 2019
ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.
FDA Enforcement
Class II
·Terminated·KCI USA, INC.·January 13, 2016
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian; PT=Portuguese; ES=Spanish; JP=Japanese; PL=Polish; RU=Russian
FDA Recall
Terminated
·Event Medical·Product code CBK·August 12, 2005