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

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    NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040109929·OBTURATOR - OBT20 - SIZE 30 Obt 20pk CHC3

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65820203171·OBTURATOR - OBT20 - SIZE 30 Obt 20pk CHC3

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717103162·Midway Select Disposable Diamonds 856-021F, Pkg/25

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036020064·

    MODEL 9000 BARIATRIC WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM

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

    SM104 M-SERIES W/5TH WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 25, 2013

    FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33 %, CELL

    FDA Adverse Event
    Other ·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·March 14, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·March 26, 2008

    Calix P PEEK Lumbar System, PLIF Rasp

    FDA Enforcement
    Class II ·Terminated·X Spine Systems Inc·October 26, 2016

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016