BEUDAMED
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    2.0/2.4 CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890107830·Zirlux Multi-Unit Abutment 1 mmH compatible wit...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450124680·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033237717·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033237724·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033237700·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033237649·

    DIRECT TIBC CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 19, 2025

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 18, 2025

    ENDOPATH** ETS45

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 19, 2013

    TRABECULAR METAL FEMORAL STEM PRESS-FIT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·March 2, 2011

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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