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

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    MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809866230·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...

    SOAR Retractor System

    FDA UDI
    SPINEOLOGY INC.·M7403042606·26mm x 60mm Portal Tube

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981183059·15x13x06mm Rasp, Flat

    OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 14, 2026

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 2, 2013

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 6, 2011

    LD CV EZTRK 2 BP IS1 4543 90CM US

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWP·May 8, 2008

    SLEEV 2PART L50 F/MEF

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·October 12, 2018

    Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.)

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LFR·November 9, 2005

    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

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015