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

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    EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Phonak

    FDA UDI
    Phonak AG·07612847985988·Naída S CRT V (pure transparent)

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 11, 2019

    NIPRO SAFETOUCH SAFETY FISTULA NEEDLE

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

    STEERABLE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 23, 2013

    OLYMPUS TELESCOPES

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FBP·March 31, 2011

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015