BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GC Fuji®

    FDA UDI
    Gc America Inc.·14548161321983·GC Fuji® Automix LC Set - Cartridge A3 shade + ...

    GC Fuji®

    FDA UDI
    Gc America Inc.·D0470127141·GC Fuji® Automix LC Set - Cartridge A3 shade + ...

    NA

    FDA UDI
    Stryker GmbH·00886385005195·Cortical Screw, Self-tap., T6 Drive

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120140·Screwdriver, Polyaxial, Standard, Cannulated, L...

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795133892·2.7mm x 14mm, Threaded Peg, Ti

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033440469·

    Lumbar Interbody Fusion System (OLLIF)

    FDA UDI
    ADVANCED RESEARCH MEDICAL LLC·00850014575113·Lumbar Interbody Fusion System (OLLIF) Oblique ...

    EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830

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

    WARTNER WART REMOVAL SYSTEM

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

    True Position® Spacer System

    FDA UDI
    Spine Wave, Inc.·10840642107548·Implant, Lordotic, 27 (L) x 14 (H) mm, 7°

    True Position®

    FDA UDI
    ATLAS SPINE, INC.·M68112080127140·27mm x 14mm Lordotic Spacer

    BARD PARKER

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, INC.·Product code GES·February 22, 2013

    PROXIMATE** SKIN STAPLER 35 WIDE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDT·March 10, 2011

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORPORATION·Product code NBW·March 11, 2008

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018