BEUDAMED
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    GSA GENITO SENSORY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Neurology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890109810·Zirlux Titanium Abutment Blank compatible with:...

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964152849·Endo Carry-on Procedure Kit contains Basin, Int...

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036284398·

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036141271·

    ARTIFICIAL URINARY SPHINCTER

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code EZY·March 14, 1997

    MINIMED MIO ADVANCE

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·September 19, 2025

    DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500

    FDA 510(k)
    FDA Class 2 ·Immunology

    CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX

    FDA 510(k)
    FDA Class 2 ·Dental

    GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·October 18, 2023

    MULTIFIRE ENDO GIA 30-3.5 12MM STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC·Product code GDW·March 11, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 8, 2011

    QUICKSITE XL LV

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    Oridion Surestream CO2 Sampling Lines- Smart SureLine Plus O2 adult Part Number: 010981-03 Product Usage: The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.

    FDA Recall
    Terminated ·Oridion Medical·Product code CCK·December 1, 2011

    Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling Lines: SureLine Adult Part No.010976; sureLine Pediatric Part No. 010977; SureLine O2 Adult Part No.010979; SureLine O2 Pediatric Part No.010980 Smart SureLine Plus O2 Adult Part No. 010981; Smart SureLine O2 Pediatric Part No. 010982; Smart SureBloc O2 Part No. 010983; Watertrap (package of 25 units) Part No. 010994; Sure VentLine Set Adult/Pediatric Part No.010986; Sure VentLine H Set Adult/Pediatric Part No.010987; Smart SureLine Guardian O2 Part No.012533; Smart SureLine Guardian O2 Long Part No.012534;

    FDA Recall
    Terminated ·Oridion Medical·Product code CCK·February 16, 2012

    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 19, 2019

    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 Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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