BEUDAMED
    70 results · 20ms · Sources: EU EUDAMED, US FDA

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    E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

    FDA Enforcement
    Class I ·Terminated·E25Bio, Inc.·February 16, 2022

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·January 3, 2018

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

    FDA Enforcement
    Class II ·Terminated·Microbiologics Inc·March 13, 2019

    XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.

    FDA Enforcement
    Class II ·Terminated·Revmedx Inc·September 23, 2015

    Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·December 30, 2020

    MiniCap Extended Life PD Transfer Set

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDJ·November 10, 2020

    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code LXH·July 13, 2020

    BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMF·December 23, 2020

    Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code DWS·January 13, 2020

    Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OGR·November 13, 2020

    Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code FDE·November 13, 2020

    Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OGR·November 13, 2020

    Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OEZ·November 13, 2020

    Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code LRO·November 13, 2020

    The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured.

    FDA Recall
    Terminated ·C.R. Bard Inc·Product code PHU·January 13, 2020

    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 10888857108769, Size 28x4mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

    FDA Recall
    Terminated ·Product code HWJ·April 13, 2020

    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 10888857108660, Size 28x8mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

    FDA Recall
    Terminated ·Product code HWJ·April 13, 2020