BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Symmetry Rochester-Pean

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482040331·Symmetry® Forceps, Rochester-Pean Hemostatic, C...

    Orthocryl®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011161128000·Orthocryl® liquid, green/ orthodontic acrylics

    BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    SRD SCPC LEVEL BUBBLE

    FDA Adverse Event
    Death ·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 6, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·September 17, 2008

    DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    15.5MM MEDULLARY REAMER HEAD

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·June 14, 2021

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·March 23, 2018

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·August 22, 2018

    Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020