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

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    AMPLATZER VASCULAR PLUG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Field Shield OTC Wound Dressing, 1oz

    FDA UDI
    Kericure Inc.·00858071004195·Topical burn and wound dressing, hydrogel barri...

    Audit MicroControls Control FD Assayed Chemistry, Level 1

    FDA UDI
    AALTO SCIENTIFIC·B085K0311100·

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967187327·Battalion, LLIF Trial, 10°, 18 mm Wide, 10 mm X...

    MAC 5500 HD

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES·Product code DPS·October 26, 2018

    URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AVALUS AORTIC TISSUE VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020

    CANNULATED 2.5MM HEXAGONAL SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HXX·April 2, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·February 25, 2011

    DXTEND GLENOSPHERE ECC D42MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.·Product code KWS·April 17, 2008

    Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015