BEUDAMED
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    LINEZOLID, 30UG, BBL SENSI-DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00271651·

    Preat

    FDA UDI
    Preat Corporation·00842092182994·ASC Astra®-compatible Aqua 3.5/4.0 mm Titanium ...

    Reagent Set C

    FDA UDI
    M DIALYSIS INC.·07332699000355·Reagents and Calibrator A for the ISCUSflex ana...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002165·artVeneer life lower posteriors, M, BL1

    Preat

    FDA UDI
    Preat Corporation·00842092183403·ASC Astra®-compatible Aqua 3.5/4.0 mm – Milled ...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197064880·Bose Tracheal Ligature Hook, right 160mm,...

    MAMMARY PROSTHESIS

    FDA Adverse Event
    MENTOR CORP.·Product code FTR·May 23, 1994

    Palladian™

    FDA UDI
    NEUROSTRUCTURES, INC·00841508102885·Non-Cannulated Tap 6.5mm

    NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·March 13, 2013

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·February 4, 2011

    ENTRIFLEX FEEDING TUBE

    FDA Adverse Event
    TYCO HEALTHCARE/KENDALL·Product code FPD·February 22, 2008

    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

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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