BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673167·LEVAMED STABILI-TRI ANK SUP BLU L IV

    EYE SENTIAL

    FDA UDI
    FGX INTERNATIONAL INC.·00193033444757·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120240·Screwdriver, Extended Tab, Cannulated, SNI 1, L...

    PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MACS MODULAR ANTERIOR CONSTRUCT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NONE - SEE PHYSICIAN COMMENTS IN H10.

    FDA Adverse Event
    Injury ·Product code JWH·October 16, 2013

    BD INSYTE AUTOGUARD PNK 20GA X 1.16IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 19, 2022

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    RESOLUTE INTEGRITY OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·March 20, 2013

    UNKNOWN DEPUY HUMERAL CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSD·February 24, 2011

    AED PRO

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 11, 2008

    Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 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