BEUDAMED
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    GISH ARTERIAL FILTER WITH HA COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014609225·SKYTRON 3.25" SOFTCARE PLUS

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated

    CD3-FITC (Clone REA613)

    FDA UDI
    Miltenyi Biotec B.V. & Co. KG·04049934134050·REA613 recognizes the human CD3 antigen, a sing...

    RADS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·May 30, 2023

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 26, 2013

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·May 9, 2011

    CAPIOX SX25 OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTZ·July 21, 2008

    DBP PUTTY 1CC

    FDA Adverse Event
    Other ·ISOTIS ORTHOBIOLOGICS, INC.·Product code LYC·March 19, 2009

    AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 25, 2022

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 20, 2023

    TRULIANT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 31, 2023

    Allura Xper FD10; Model Number: 722003;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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