BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoverLoc™ Volar Plate

    FDA UDI
    TORNIER, INC.·00846832001330·FULLY THREADED SCREW - CORTICAL

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103120·Shaver, Closed, 12mm

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0130120·Segmental Rod Reducer Driver

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024076·Paddle Shaver, 12mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132120·Trial, TLIF, 27L OB CRV 7Deg, 12mm

    IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SIEMENS CHARGER TYPE 013-312-04

    FDA Adverse Event
    Malfunction ·SIEMENS HEARING INSTRUMENTS, INC.·Product code ESD·December 19, 2013

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·February 25, 1998

    TRUFREEZE PASSIVE VENTING CATHETER

    FDA Adverse Event
    Malfunction ·UNITED STATES ENDOSCOPY GROUP, INC.·Product code GEH·December 2, 2022

    TRUFREEZE PASSIVE VENTING CATHETER

    FDA Adverse Event
    Malfunction ·UNITED STATES ENDOSCOPY GROUP, INC.·Product code GEH·December 2, 2022

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·March 9, 1998

    TRUFREEZE SPRAY KIT

    FDA Adverse Event
    Malfunction ·UNITED STATES ENDOSCOPY GROUP, INC.·Product code GEH·May 7, 2022

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 20, 2013

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 10, 2011

    PALINDROME 23/40 SLOT SPRT W/VT

    FDA Adverse Event
    Other ·TYCO HEALTHCARE/KENDALL·Product code MPB·March 14, 2008

    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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018