BEUDAMED
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    AIACT KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950026555·LATEX TUBING 3/16"X3/32" AMBER 50' RL NS W/L

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032952·Baltic Denture System BDLoad Lm6 PLSEbil2DFl C1...

    Lip Bumper

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746156915·FIXED FUNCT LIP BUMPER 045 93MM BALL CLASP HK D...

    INSTANT-VIEW MDMA (XTC) Urine Cassette Test

    FDA UDI
    ALFA SCIENTIFIC DESIGNS, INC.·10796918000214·INSTANT-VIEW MDMA (XTC) Urine Cassette Test

    HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODULAR HEAD BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 3, 2013

    SCREW-IN

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 29, 2011

    ON-Q PAINBUSTER

    FDA Adverse Event
    Other ·I-FLOW CORP.·Product code MEB·April 23, 2008

    UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10

    FDA Recall
    Terminated ·Plus Orthopedics USA·Product code HRY·July 18, 2006

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024