BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    IMAGECHECKER CT CAD SOFTWARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    WHIP-MIX CORP.

    FDA registration
    WHIP-MIX CORP.·13 products·🇺🇸 United States

    ZAVATION

    FDA UDI
    Zavation LLC·00842166157057·HA+ ALIF 4deg 36mmx17

    ZAVATION

    FDA UDI
    Zavation LLC·00842166154834·WHITNEY 4deg 36mmx17mm

    Zavation

    FDA UDI
    Zavation LLC·00842166180505·ALIF Sizer 4eg 36mm x 17mm

    Zavation

    FDA UDI
    Zavation LLC·00842166121454·ALIF 4deg 36mm x 17mm

    DRI METHADONE METABOLITE ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS

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

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013

    TEMP PUMP TEMPERATURE

    FDA Adverse Event
    Malfunction ·STRYKER CORP DBA GAYMAR·Product code ILO·March 29, 2011

    CONTAK RENEWAL 4

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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