BEUDAMED
    14 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 ×

    5000Z SYSTEM (OTC)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033122·Baltic Denture System BDLoad BDLoad Sm7 PLSEbm...

    Power Pin

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746162121·POWER PIN 50/PK

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0381220·Egg Handle, Torque, 30 in-lbs

    EMS ELECTROSTATIC FLITER AND HME COMBINATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SMARTFLOW, MODEL SFIP 2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOSPITAL NON-VENTED FULL FACE MASK

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CBK·April 5, 2017

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 28, 2011

    GE OEC 9800

    FDA Adverse Event
    Injury ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·April 23, 2008

    NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

    FDA Enforcement
    Class III ·Terminated·Synapse Biomedical Inc·July 27, 2022

    UNKNOWN HEAD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·May 19, 2017

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024