BEUDAMED
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    Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017927·K-Wire, Double Ended, Trocar Point, Diameter 0....

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017910·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319741535·Alligator Scissors, 4" (10cm) working length, t...

    SCHWERT

    FDA UDI
    A. Schweickhardt GmbH & Co. KG·E8961904540·Bowmann lachrymal probe, Silver, cylind...

    Pre-Finisher

    FDA UDI
    TP ORTHODONTICS INC·00192029042182·4 Bicuspid Extraction

    ALLURE MB CERAMIC BRACKETS

    FDA 510(k)
    FDA Class 2 ·Dental

    HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V

    FDA 510(k)
    FDA Class 2 ·Neurology

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018

    ENDO GIA II 60-3.5 SULU

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GDW·July 29, 2011

    DERMABOND ADVANCED TOPICAL SKIN ADHESIVE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code MPN·June 26, 2013

    RESTORESENSOR MRI

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 21, 2014

    RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2022

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024