BEUDAMED
    42 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06

    FDA Enforcement
    Class II ·Terminated·Dutch Ophthalmic USA, Inc.·July 28, 2021

    CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA.

    FDA Enforcement
    Class II ·Terminated·Codan US Corporation·July 8, 2020

    EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical.

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·June 22, 2016

    uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

    FDA Enforcement
    Class II ·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·August 19, 2020

    Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.

    FDA Enforcement
    Class II ·Terminated·Fukuda Denshi USA, Inc.·January 27, 2016

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112

    FDA Enforcement
    Class II ·Terminated·WRP Asia Pacific Sdn Bhd·June 6, 2018

    BD Viper LT software, version 3.00H

    FDA Enforcement
    Class II ·Terminated·Bd Diagnostic·April 26, 2017

    Software version 4.44A utilized on the BD MAX System

    FDA Enforcement
    Class II ·Terminated·BD LIFE SCIENCES·April 26, 2017

    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

    FDA Enforcement
    Class II ·Terminated·BD SWITZERLAND SARL·May 20, 2020

    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

    FDA Enforcement
    Class II ·Terminated·BD SWITZERLAND SARL·May 20, 2020

    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

    FDA Enforcement
    Class II ·Terminated·BD SWITZERLAND SARL·May 20, 2020

    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

    FDA Enforcement
    Class II ·Terminated·BD Biosciences, Systems & Reagents·July 9, 2014

    Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.

    FDA Enforcement
    Class II ·Terminated·BD Biosciences, Systems & Reagents·May 7, 2014

    BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.

    FDA Enforcement
    Class II ·Terminated·BD Biosciences, Systems & Reagents·September 26, 2012

    BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.

    FDA Enforcement
    Class II ·Terminated·BD Biosciences, Systems & Reagents·April 8, 2015

    CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent

    FDA Enforcement
    Class II ·Terminated·BD Biosciences, Systems & Reagents·April 8, 2015

    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.

    FDA Enforcement
    Class II ·Terminated·BD Biosciences, Systems & Reagents·January 28, 2015