BEUDAMED
    10 results · 18ms · 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.

    KETOREX SANWA STANDARDS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517961778·Brigade Lateral Trial, 7x34x28mm 8°

    SureLOK Pedicle Screw System

    FDA UDI
    PRECISION SPINE, INC.·00815362021866·SureLOK MIS ø6.5mm Cannulated Pedicle Screw Tap

    Sure-Lok Pedicle Screw System

    FDA UDI
    PRECISION SPINE, INC.·00840019922722·6.5mm Cannulated Pedicle Screw Tap

    DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A

    FDA 510(k)
    FDA Class 2 ·Radiology

    S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)

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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·November 10, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 14, 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