BEUDAMED
    16 results · 71ms · Sources: EU EUDAMED, US FDA

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    Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    CURAPLEX

    FDA Adverse Event
    Injury ·BOUND TREE MEDICAL, LLC·Product code CAE·February 28, 2020

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Enforcement
    Class II ·Terminated·POM Medical LLC·November 6, 2019

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Recall
    Terminated ·POM Medical LLC·Product code BYG·July 11, 2018

    Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Number 45-020; 4) 8F/SL/Plastic Port/F, Product Number H965450220, Catalog Number 45-022; 5) 8F/SL/Titanium Ports/F, Product Number H965450250, Catalog Number 45-025; 6) Plastic/6F/non-filled/non-valved, Product Number H965450290, Catalog Number 45-029; 7) Plastic/6F/filled/non-valved, Product Number H965450300, Catalog Number 45-030; 8) Plastic/8F/non-filled/non-valved, Product Number H965450310, Catalog Number 45-031; 9) Plastic/8F/filled/non-valved, Product Number H965450320, Catalog Number 45-032; 10) Plastic/6F/non-filled/valved, Product Number H965450370, Catalog Number 45-037; 11) Plastic/6F/filled/valved, Product Number H965450380, Catalog Number 45-038; 12) Plastic/8F/non-filled/valved, Product Number H965450390, Catalog Number 45-039; 13) Plastic/8F/filled/valved, Product Number H965450400, Catalog Number 45-040; 14) Titanium/6F/non-filled/valved, Product Number H965450410, Catalog Number 45-041; 15) Titanium/8F/non-filled/valved, Product Number H965450430, Catalog Number 45-043. Product Usage: ***K-Shield Port Access Infusion Set, (affected product) supplied by Kawasumi Laboratories. The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion. This device is also indicated for injection of contrast media by a power injector only with power injectable implanted port.***NMI Port is indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

    FDA Recall
    Terminated ·Navilyst Medical, Inc.·Product code FPA·November 25, 2013

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices