BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    NAFD 100

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Safco NiTi RL Rotary Files

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310208483·Safco NiTi RL rotary files, #25, (0.6 taper / 2...

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221062833·Mini Uni-Twin(TM) Bracket APC(TM) II UR3 -7T/11...

    APC™ PLUS Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221093851·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR3 -7T/...

    SPO2 WRAP SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TDK HANDPIECES

    FDA 510(k)
    FDA Class 1 ·Dental

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007

    GREENLIGHT HPS LASER SYSTEM

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·March 18, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 16, 2011

    OneTouch/Basic/Profile Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese)

    FDA Recall
    Terminated ·Medishop USA·Product code NBW·October 17, 2006

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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