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

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    CUTERA GENESISPLUS LASER SYSTEM

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

    Galaxy

    FDA UDI
    DIOMEDICAL CO.,LTD.·08809263396729·Galaxy ACIF cage H10 x W36 x L26

    Keyhole 2-Loop Archwire

    FDA UDI
    Ortho Arch Company Inc·D90910362615·.016 X .022 RIGHT FORM KEYHOLE 2-LOOP 26MM (10)

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A103626150·10mm H x 36mm W x 26mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A10362680·10mm H x 36mm W x 26mm L x 8 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A103626120·10mm H x 36mm W x 26mm L x 12 degrees ALIF

    DEVILBISS HUMIDIFIER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200

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

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    TRILOGY LONGEVITY CROSSLINKED POLY LINER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·May 16, 2011

    DELTAXSFT10 1.5MM X 1CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·September 22, 2021

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015