BEUDAMED
    90 results · 22ms · Sources: EU EUDAMED, US FDA

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    AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.

    FDA Recall
    Terminated ·Oscor, Inc.·Product code DYB·March 10, 2021

    TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NAW·July 23, 2021

    SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA

    FDA Recall
    Terminated ·Sunstar Americas, Inc.·Product code EAX·March 23, 2021

    TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NAW·July 23, 2021

    Merge Hemo, Software packages 10.2, 10.3, and 10.4

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code DQK·July 23, 2021

    MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

    FDA Recall
    Terminated ·Mivi Neuroscience Inc·Product code DQY·July 23, 2021

    MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

    FDA Recall
    Terminated ·Mivi Neuroscience Inc·Product code DQY·July 23, 2021

    Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HTW·February 24, 2021

    Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.

    FDA Recall
    Completed ·Exactech, Inc.·Product code LZO·June 29, 2021

    Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.

    FDA Recall
    Completed ·Exactech, Inc.·Product code LZO·June 29, 2021

    Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)

    FDA Recall
    Terminated ·Kinsman Enterprises Inc·Product code IKZ·September 10, 2021

    GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

    FDA Recall
    Terminated ·Vero Biotech, LLC·Product code MRN·May 19, 2021

    ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

    FDA Recall
    Terminated ·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·March 1, 2021

    SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·August 20, 2021

    Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

    FDA Recall
    Open, Classified ·Aesthetics Systems Usa Inc·Product code ITX·August 23, 2021

    QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200

    FDA Recall
    Terminated ·Z-Medica, LLC·Product code FRO·September 22, 2021

    SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·August 20, 2021

    Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l

    FDA Recall
    Terminated ·Trinity Sterile, Inc.·Product code OXQ·February 23, 2021

    Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code MFD·February 28, 2020

    Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489

    FDA Recall
    Open, Classified ·W. L. Gore & Associates Inc.·Product code MJN·July 12, 2021