BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    POCKETCPR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Conmed/Linvatec

    FDA UDI
    Provision·B504OM50713210·

    Conmed/Linvatec

    FDA UDI
    Provision·00810041065933·

    INTREX

    FDA UDI
    Conmed Corporation·10845854011140·INTREX LARGE BONE OSCILLATING SAW BLADE 25.0 X ...

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 28, 2021

    MODIFICATION TO XPS 3000 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ALL-PRO 2010

    FDA 510(k)
    FDA Class 2 ·Radiology

    XPS® BUR GUARD - VISAO®

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ERL·April 22, 2016

    XPS® BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·March 13, 2017

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·April 22, 2013

    MEDTRONIC

    FDA Adverse Event
    Death ·MEDTRONIC·Product code LKK·April 21, 2011

    EMBOSHIELD EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR GALWAY·Product code NTE·July 8, 2008

    EVEREST ® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·STRYKER-SPINE·Product code LXH·September 9, 2019

    Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

    FDA Enforcement
    Class II ·Terminated·ArthroCare Medical Corporation·December 17, 2014

    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

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024