BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE N-PE MICROKERATOME BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Safco Gates Glidden Drills

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310222053·Safco Gates Glidden drills, #02, 28mm, 6/box

    Woven Filiform Coude Tip

    FDA UDI
    C. R. Bard, Inc.·00801741073205·Woven Filiform Coude Tip

    Cook

    FDA UDI
    COOK INCORPORATED·00827002140387·Whistle Tip Ureteral Catheter (Left)

    Whistle Tip

    FDA UDI
    COOK INCORPORATED·00827002149526·Whistle Tip Ureteral Catheter (Left)

    GLUCOMETER DEX TEST SENSOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARONY

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 26, 2013

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 11, 2011

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 26, 2008

    GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code PZE·May 10, 2022

    MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 9, 2023

    SYNERGY XD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·August 3, 2022

    BD ALARIS¿ SMARTSITE¿ EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 23, 2023

    WHISTLE TIP URETERAL CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KOD·August 2, 2023

    Portex Hypodermic Needle-Pro 5 ml Syringe, 20g x 1 '' Needle Catalog Number: 4250

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·September 9, 2004

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013