BEUDAMED
    19 results · 28ms · 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.

    PALMLIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    Affiniti™

    FDA UDI
    TORNIER, INC.·00846832002108·

    Safco Daily Plus Bibs

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063752375·Safco Daily Plus bibs Light Blue, 500/case

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717100550·Gloves Latex Powder-Free Large, Pkg/100

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036018986·

    MicroChoice

    FDA UDI
    Conmed Corporation·10845854023136·MicroChoice REPLACEMENT SAFE SLIDE

    EECP THERAPY SYSTEM, MODEL TS3

    FDA Adverse Event
    Injury ·VASOMEDICAL, INC.·Product code DRN·December 30, 2002

    RADIONICS LUMBOPERITONEAL SHUNT

    FDA 510(k)
    FDA Class 2 ·Neurology

    BROOKER TIBIA NAILS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD

    FDA Adverse Event
    Injury ·BECTON DISCKINSON AND CO·Product code KYX·June 25, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 25, 2013

    UNKNOWN PRODUCT - RIGHT STRYKER KNEE

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·March 10, 2011

    VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FTM·December 11, 2020

    1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

    Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·December 26, 2012

    Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020057. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.

    FDA Recall
    Terminated ·Tournier, Inc.·Product code KWS·October 20, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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