BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    RIVA LUTING

    FDA 510(k)
    FDA Class 2 ·Dental

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502327·CROSS HAIR TARGET, STAINLESS - ingoing part CRO...

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291102014·SS Suture, 7 per sleeve

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319701515·Nail & Bone Rasp 6-3/4" (17cm), double ended, b...

    APOLLO MOBILE C ARM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NOVA CORDLESS CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    REBOUND HRD

    FDA Adverse Event
    Malfunction ·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON-IRVINE TECHNOLOGY CENTER·Product code HQC·April 3, 2013

    REVERSE GLENOSPHERE IMPACTOR HEAD

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HWA·February 15, 2011

    APEX PUSH MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·May 7, 2008

    PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. 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

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024