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    MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040064600·MOLAR BAND LL 1ST 42 (2)

    Mini-Mono® Brackets

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70602361·Mini-Mono-Brackets Andrews 'N' .018" 200 Bracke...

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code DTB·November 29, 2006

    PHILOS DR

    FDA Adverse Event
    BIOTRONIK GMBH AND CO.·Product code DTB·November 29, 2006

    Logical Lateralised 20° Hooded Liner

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215095345·

    IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYNERGY VLS CAP NUT MODELS 2206, 6102

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 16, 2013

    VANGUARD ANTERIOR STABILIZED TIBIAL BEARING 12MM X 83MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·April 15, 2011

    CAPTIFLEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FDI·June 6, 2008

    INCLUSIVE TAPERED IMPLANT 4.2 MMD X 13 MML X 3.5 MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 7, 2020

    INCLUSIVE TAPERED IMPLANT 4.2 MMD X 13 MML X 3.5 MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 1, 2020

    Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-06023. 6 mm x 20 mm x 130 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall. The Innova Self-Expanding Stent is available in a variety of diameters and lengths. The delivery system is also offered in two working lengths (75 cm and 130 cm). The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code NIP·May 19, 2011

    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

    FDA Enforcement
    Class I ·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025