BEUDAMED
    50 results · 11ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments.

    FDA Recall
    Terminated ·Selectivemed Components Inc·Product code EGJ·March 15, 2005

    iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.

    FDA Recall
    Terminated ·Tapemark Company·Product code EGJ·November 10, 2021

    Hidrex USA DVP1000

    FDA Recall
    Terminated ·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017

    Hidrex USA DP450

    FDA Recall
    Terminated ·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017

    Daavlin Aquex (DAAV1000)

    FDA Recall
    Terminated ·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017

    VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·December 22, 2020

    I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·January 1, 2011

    Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·December 22, 2020

    I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·August 8, 2012

    VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 18, 2018

    VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·April 11, 2018

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Abbott Point of Care inc., Abbott Park, IL 60064 USA Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CHL·February 23, 2009

    Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·January 27, 2021

    i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor, NJ 08520. Made in Canada. i-STAT Catalog Number -- 220300; Abbott List Number (US and Canada)-- 06F01-01; Abbott List Number (Rest of World) -- 06F01-02.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JGS·May 24, 2006

    i-STAT EG6+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code JPI·February 5, 2010

    i-STAT EG7+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code JPI·February 5, 2010

    i-STAT G3+ Cartridge; pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for calculated HCO3 and PO2 for calculated oxygen saturated/sO2. Catalog Number 220100. Abbott Point of Care Inc., Abbott Park, IL 60064 The iSTAT G3+ Cartridge is intended to be used to quantitatively measure oxygen, carbon dioxide, and pH.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CHL·February 23, 2009

    VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·May 17, 2018