BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    SECTRA OSTEOPOROSIS PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSTONE CONTROL™ Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169108929·SPACER 4021527 18 DEG 15X27

    Capstone Control PTC Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169677678·SPACER 5021527 CONTROL PTC 18 DEG 15X27

    FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES

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

    PRAXSYS RELIA TSH TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    M2A-38 CUP NON FLARED SZ 54MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 26, 2013

    ECHELON RELOAD

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 17, 2011

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·March 26, 2008

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·May 7, 2019

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·July 14, 2017

    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

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 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