BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    VKS KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Safco polycarbonate crowns

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310222043·Safco polycarbonate crowns #24 5/box

    Woven Filiform Coude Tip

    FDA UDI
    C. R. Bard, Inc.·00801741073199·Woven Filiform Coude Tip

    Cook

    FDA UDI
    COOK INCORPORATED·00827002140370·Whistle Tip Ureteral Catheter (Left)

    DELTA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540337505·DELTA 2.2X4MM SCREW, 2 EA

    Whistle Tip

    FDA UDI
    COOK INCORPORATED·00827002172623·Whistle Tip Ureteral Catheter (Left)

    TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONMED MACROLYTE #402-2204

    FDA Adverse Event
    Other ·CONMED CORP.·Product code GEI·November 12, 1997

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    CHIEN TI ENTERPRISE CO. LTD·Product code INI·March 26, 2013

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

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

    ELECSYS 2010 RACK

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

    CONMED

    FDA Adverse Event
    Other ·CONMED ELECTROSURGERY·Product code GEI·April 12, 2007

    CONMED

    FDA Adverse Event
    Other ·CONMED ELECTROSURGERY·Product code GEI·April 12, 2007

    BD ALARIS¿ SMARTSITE¿ EXTENSION SET

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

    PS TIBIAL INSERTS SZ 2, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 13, 2025

    Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.

    FDA Enforcement
    Class III ·Terminated·Medtest Holdings, Inc.·May 24, 2017

    General Laparoscopic Tray, Product #TGL53.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code LFL·November 25, 2003

    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

    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