BEUDAMED
    13 results · 26ms · 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 ×

    MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K

    FDA 510(k)
    FDA Class 1 ·Dental

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032234·Baltic Denture System BDLoad Mm6 PLSEbim6DFm A3...

    ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOSCOPIC PLICATION SYSTEM

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

    XORAN

    FDA Adverse Event
    Malfunction ·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011

    FLEXI-SEAL FMS

    FDA Adverse Event
    Other ·CONVATEC·Product code KNT·June 7, 2006

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 3, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 29, 2011

    MEDI-CHOICE OWENS AND MINOR

    FDA Adverse Event
    Malfunction ·BOVIE MEDICAL·Product code GEI·April 18, 2008

    FLEXI-SEAL FECAL MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·CONVATEC INC.·Product code KNT·October 20, 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

    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

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014