BEUDAMED
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    EASYRA GLU-H REAGENT, MODEL 10200

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Micasept Ciradur Scissors

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896115262·Micasept Ciradur Scissors Blunt/Blunt Up Openin...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065777·INTRAORAL ELASTICS 6,5 oz 1/8" brown

    BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MASTERGRAFT RESORBABLE CERAMIC GRANULES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINEAR ST

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 23, 2024

    SYRINGE 5ML LL SP125

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 24, 2021

    SPAREREAMERTUBE F/309.065

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTO·May 3, 2013

    COULTER LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·September 16, 2014

    STRATA II VALVE, REGULAR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·May 3, 2011

    CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·February 8, 2023

    INCLUSIVE TAPERED IMPLANT 5.2MMD X 10 MML X 4.5 MMP

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 30, 2022

    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) REF 21-7649-24JP. Computerized Ambulatory Delivery Device

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·February 8, 2023

    Endopath Probe Plus II, Open End Suction/Irrigation Canula, 10mm shaft, 34 cm length, Code EPS11.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GCJ·April 20, 2006

    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