BEUDAMED
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    ULTRASONIC NEBULIZER, MODEL NE-520

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Ionosphere

    FDA UDI
    HENRY SCHEIN, INC.·H65810021531·Ionosphere 2 Spill 600mg Fast Set 500 jar

    Preat

    FDA UDI
    Preat Corporation·00842092182635·ASC Astra Aqua 3.5mm/4.0mm-Compatible Titanium ...

    NGSgo-IndX Plate I (Indices Illumina)

    FDA UDI
    GenBio·00613745002705·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002153·artVeneer life lower posteriors, L, D4

    MAMMARY PROSTHESIS

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

    SURGITEK MAMMARY PROSTHESIS

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

    ARTHRO-SURGIMAT-A103

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM

    FDA 510(k)
    FDA Class 2 ·Neurology

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 26, 2026

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 11, 2013

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·February 28, 2011

    KARL STORZ LAPAROSCOPE

    FDA Adverse Event
    Malfunction ·KARL STORZ ENDOSCOPY-AMERICA, INC.·Product code GCJ·January 22, 2008

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

    PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG kit contains all of the reagents necessary to perform the assay.

    FDA Enforcement
    Class II ·Terminated·Genetic Testing Institute,inc·January 28, 2015

    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

    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