BEUDAMED
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    POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6911040408·CUBE PESSARY W/ DRAINAGE HOLES #8

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291102168·SS Suture, 2 per sleeve

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319700082·Scalpel Handle #4 - for blade sizes #20-25, ext...

    Arrigo Professional Supplies LLC

    FDA UDI
    ARRIGO PROFESSIONAL SUPPLIES LLC·00850072625065·Gauze Sponge, Non Sterile, 4"x4", 8ply, Non fol...

    Up&Up Tampons

    FDA UDI
    TARGET CORPORATION·00834533004729·

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023209·B-P HIP FEMORAL STEM W/O HEAD, W/O BIOCOAT & W/...

    LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF

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

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·April 3, 2013

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·May 7, 2008

    HI-TORQUE STEELCORE 18 GUIDE WIRE WITH MICROGLIDE COATING

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·April 5, 2011

    AXIUM PRIME BARE PL 3D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code KRD·October 9, 2025

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025