BEUDAMED
    10 results · 20ms · 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 ×

    GORE BALLOON SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Y-Connector

    FDA UDI
    C. R. Bard, Inc.·00801741049576·Universal Y-Connector, 1/4" Crabclaw-Style Y-Co...

    3D

    FDA UDI
    Rmo, Inc.·00885797100160·3D QUAD HELIX WILSON ASST OF 6

    PROVIEW MEDICAL IMAGE DISPLAY MODULE

    FDA 510(k)
    FDA Class 2 ·Radiology

    BCI ADVISOR VITAL SIGNS MONITOR (9200)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SERIES A PAT W/WR THN 28 1 PEG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·January 12, 2022

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·April 22, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 14, 2011

    LIFEPAK 9 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·July 3, 2008

    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·October 15, 2014