BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    TIMETER PRODUCED PURRITAN BENNETT O2 ADP

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NUPRO® Sensodyne® Prophylaxis Paste with Fluoride and NovaMin®

    FDA UDI
    DENTSPLY INTERNATIONAL INC.·D0038015141·NUPRO® Sensodyne® Prophy Paste, Citrus Mint, Po...

    24M - Duke Energy FA/BBP

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015149·24M - Duke Energy FA/BBP

    ACUMED

    FDA UDI
    Acumed LLC·10806378049408·ARH Slide-Loc™ Tray Base

    BD DIRECTIGEN EZ RSV

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER

    FDA 510(k)
    FDA Class 2 ·Dental

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·October 5, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·October 16, 2007

    MLX 300W XENON LIGHT SOURCE

    FDA Adverse Event
    Malfunction ·INTEGRA BURLINGTON, MA, INC.·Product code FST·October 18, 2012

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.

    FDA Enforcement
    Class II ·Terminated·Acumed LLC·June 7, 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