BEUDAMED
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    HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEYER-SCHULTE BREAST IMPLANT

    FDA Adverse Event
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.·Product code FTR·June 14, 1994

    REPLICON NATURAL Y POLYURETHANE COATED BREAST IMPLANT

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·June 14, 1994

    MEGA NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·March 13, 2013

    NEWLIFE

    FDA Adverse Event
    Malfunction ·AIRSEP CORP.·Product code CAW·January 28, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 12, 2014

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018

    OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018

    COMPR VRS GLEN PPS MIN TPR ADR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·February 4, 2022

    UNKNOWN LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·February 4, 2022

    CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·October 5, 2022

    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

    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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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