11 results
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27ms
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Sources: EU EUDAMED, US FDA
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
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
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
NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP, Part Number 08500019
FDA Enforcement
Class II
·Terminated·Aribex Inc·September 14, 2016
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 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
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 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
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·November 14, 2018