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

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    SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS

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

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502952·OPEN MR-INDICATOR - PLATE RIGHT

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291102069·SS Suture, 1 per sleeve

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319700624·Scalpel Blade Remover 2" (5cm)

    SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

    FDA 510(k)
    FDA Class 2 ·Hematology

    MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACRYSOF RESTOR

    FDA Adverse Event
    Malfunction ·ALCON -RESEARCH LTD/HUNTINGTON·Product code HQL·April 3, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·April 5, 2011

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CEM·May 7, 2008

    ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. 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

    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

    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