BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    NAVIGATOR HD URETERAL ACCESS SHEATH SETS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Critical Cover

    FDA UDI
    Alpha Pro Tech, Inc.·10817583021905·Coverall, GenPro, White, Inset Sleeve, Zip Clos...

    ELEVATION

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    POLARIS SPINAL SYSTEM -TRANSLATION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROD, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

    5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 31, 2013

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·June 16, 2011

    BLUE LINE CUFFED ORAL/NASAL ENDOTRACHEAL TUBE

    FDA Adverse Event
    Malfunction ·MFG FOR SMITHS MED BY: SMITHS HEALTHCARE MFG S.A. DE C.V.·Product code BTR·June 6, 2008

    POLARIS SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020

    PEDICLE SCREW UNSPECIFIED

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

    PEDICLE SCREW UNSPECIFIED

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·February 11, 2020

    PEDICLE SCREW UNKNOWN TYPE/SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

    CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·December 3, 2020

    HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

    FDA Adverse Event
    Injury ·B. BRAUN SURGICAL SA·Product code MPN·February 26, 2020

    POLARIS TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

    PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015