BEUDAMED
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    ACTICLOT PROTEIN S, MODEL 843L

    FDA 510(k)
    FDA Class 2 ·Hematology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890123860·Zirlux Shading Liquid - Dentin, B2, 100ml

    Affinity™ Inflex FS Mega Mix 380mL

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883005986·VPS Impression Tray Material

    Affinity™ Inflex FS Mega Mix 380ml

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172017022·VPS Impression Tray Material

    XTRA SIGHT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033398067·

    XTRA SIGHT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033398050·

    XTRA SIGHT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033398043·

    DUO-DENT DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    56MM AND R3 ACETABULAR SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

    DESARA

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code FTL·March 7, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 9, 2011

    LEGEND STIM

    FDA Adverse Event
    Other ·CHATTANOOGA GROUP·Product code GZJ·March 7, 2008

    OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·June 26, 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

    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