BEUDAMED
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    MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040009482·Zirlux 16+ C2 coloring liquid

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694000154·1.6mm x 12mm Partially Threaded Auto-Drive Screw

    RESPONDER 5, ENHANCED

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828192835·RESPONDER 5, ENHANCED

    OneCath

    FDA UDI
    COMPACTCATH, INC.·00852141007154·The OneCath Intermittent Urinary Catheter is a ...

    OneCath

    FDA UDI
    COMPACTCATH, INC.·00852141007468·The OneCath Intermittent Urinary Catheter is a ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694043991·1.6mm x 12mm Partially Threaded Auto-Drive Screw

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VECTORVISION KNEE

    FDA 510(k)
    FDA Class 2 ·Neurology

    0009613348-2024-011612

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·September 2, 2024

    ADVANCE(R) PRESSFIT KEEL

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code MBH·March 19, 2013

    HALF DAY INFUSOR, 5ML/HR 12PK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 9, 2011

    OLYMPUS

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDT·March 12, 2008

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 7, 2021

    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 Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    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