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

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    ISS INTEGRATED SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TASMIN R 6°

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844014615·The basic shape of the TASMIN R devices is a ho...

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189737·LEVAMED ACTIVE ANKLE SUP BLACK L IV

    MI Product Line

    FDA UDI
    Medical Illumination International Inc.·00816835020164·MI-1000 Minor Surgical Light, Single Ceiling

    VISION LED

    FDA UDI
    Avante·00815871022187·DRE Vision LED, SINGLE CEILING

    MI Product Line

    FDA UDI
    Medical Illumination International Inc.·00816835020720·MI-1000 Minor Surgical Light, Single Ceiling

    VISION LED

    FDA UDI
    Avante·00815871022224·DRE Vision LED, SINGLE CEILING

    FORMA SCIENTIFIC DIRECT HEAT INCUBATORS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IMMEDIATE STABILIZING DEVICE (ISD)

    FDA 510(k)
    FDA Class 2 ·Dental

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·March 31, 2016

    TOTALCAR BARIATRIC

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 27, 2013

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·March 16, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LKK·June 17, 2008

    MI-1000

    FDA Adverse Event
    Malfunction ·MEDICAL ILLUMINATION INTRNATION INC.·Product code FST·March 3, 2021

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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