BEUDAMED
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    MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    2.4/2.7MM TMS SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036009540·

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427231·

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427224·

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427248·

    ALPHA DX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PACIFIER THERMOMETER MODELS VT-901F, VT901C

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INF SET NERIA GUARD 60CM 9MM

    FDA Adverse Event
    Malfunction ·INTRA PUMP INFUSION SYSTEMS/COVATEC, INC./UNOMEDICAL A/S·Product code FPA·January 12, 2026

    ISOLINE

    FDA Adverse Event
    Injury ·SORIN CRM·Product code MRM·March 15, 2013

    DRILL ATTACHMEND MQC FOR PEN DRIVE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·August 15, 2014

    DUR MAR NEUT LINER 28IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 24, 2011

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020