BEUDAMED
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    DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102657·Astra®-compatible Lilac 4.5/5.0mm X 6mm Titaniu...

    Procure

    FDA UDI
    Twin Med, LLC·10840330700242·HMEF Adult Inline Mini W/Sampling Port 150 - 10...

    HMEF

    FDA UDI
    WESTMED, INC.·00709078014246·HMEF Adult Inline Mini W/Sampling Port 150 - 10...

    RAN-1115H2S C#0002262

    FDA UDI
    RANFAC CORP.·M979G65X0·RAN-1115H2S C#0002262 PN 74290-01M

    BREAST IMPLANT

    FDA Adverse Event
    UNKNOWN·Product code FTR·May 26, 1994

    THERMAL CAUTERY FORCEPS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BOHN FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DYB·June 14, 2023

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 16, 2024

    LINOX SMART SD 60/16

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVY·March 13, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 28, 2011

    PINN CAN BONE SCREW 6.5MMX35MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NDJ·February 20, 2008

    General Line Full Body Drape, catalog #900-2262 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014

    General Line Full Body Drape, catalog #900-2262 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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