BEUDAMED
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    DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040073377·Carbide Bur FG 57

    IMPULSE SELECT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TEMPO AQUA ANGIOGRAPHIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 14, 2013

    HOMECHOICE CYCLER-REFURBISHED

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

    AUTOCAT2 WAVE

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·February 8, 2008

    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    FDA Enforcement
    Class II ·Terminated·Physician Engineered Products, Inc.·September 9, 2015

    HANDLE BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·September 2, 2025

    EPIDURAL CATHETERIZATION KIT

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BSO·July 13, 2021

    EPIDURAL CATHETERIZATION KIT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code BSO·April 14, 2022

    EPIDURAL CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code BSO·June 6, 2022

    EPIDURAL CATHETERIZATION SET NRFIT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code CAZ·May 25, 2022

    EPIDURAL CATHETERIZATION KIT NRFIT

    FDA Adverse Event
    Malfunction ·Product code OFT·September 23, 2021

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; 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