BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems

    FDA 510(k)
    FDA Class 2 ·Dental

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023487·Ø12MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    SCOPE HOLDER DRAPE

    FDA UDI
    ADVANCE MEDICAL DESIGNS, INC.·00848340006708·DISPOSABLE EQUIPMENT COVER

    Wingman

    FDA UDI
    STRYKER CORPORATION·07613327061284·Tube Set/Activation Button for Scope Holder, Do...

    Wingman

    FDA UDI
    STRYKER CORPORATION·07613327056259·Scope Holder

    STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ZHAOFENG

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RELAY

    FDA Adverse Event
    Malfunction ·INTERMEDICS, INC.·Product code DXY·December 18, 1996

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    INTEGRITY AFX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·September 9, 2011

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·July 22, 2013

    REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 23, 2023

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·September 1, 2023

    MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 3, 2019

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013