BEUDAMED
    18 results · 33ms · Sources: EU EUDAMED, US FDA

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    ADMIRAL XTREME PTA BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00856402006191·Decan Stopper Size 8 Closure 1/2

    Hager Avions Blue/Clear Lens Slim Fit/Wraparounds

    FDA UDI
    HAGER WORLDWIDE, INC.·D2481009211·Protective Eyewear

    Copper Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989027396·COPPER NiTi 35 BAF 17x17 UPSM PK/10

    RONGEUR CITELLI 2.5mm

    FDA UDI
    W.H. Holden, Inc.·D9281009210·

    Genius Tibial Trial Tray Monobloc - Size 1

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215072476·

    McKesson

    FDA UDI
    MCKESSON MEDICAL-SURGICAL INC.·00612479242036·Therapy Putty firm resistance level 1 lb

    ADVANTAGE MARIJUANA (THC) HOME DRUG TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BAYER ADVIA IMS SYSTEM; 200 + 3

    FDA 510(k)
    FDA Class 2 ·Immunology

    PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

    VASC BAND

    FDA Adverse Event
    Injury ·LEPU MEDICAL TECHNOLOGY CO., LTD.·Product code DXC·September 19, 2014

    NEWPORT HT50 VENTILATOR

    FDA Adverse Event
    Injury ·NEWPORT NMI INC·Product code CBK·May 18, 2011

    ADULT NASAL CANNULA

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code CAT·April 13, 2011

    FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

    FDA Enforcement
    Class II ·Ongoing·Envisiontec US Llc·February 23, 2022

    FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth

    FDA Enforcement
    Class II ·Ongoing·Envisiontec US Llc·February 23, 2022

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012