BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    Barrier Supreme Sterilization Wrapper

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PARCUS PEEK CF PUSH-IN SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALINITY S HIV AG/AB COMBO REAGENT KIT

    FDA Adverse Event
    Injury ·ABBOTT GMBH·Product code QHM·April 21, 2022

    OT VERIO IQ METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 18, 2014

    CAPTURE-R SELECT

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·October 10, 2014

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·July 7, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013

    ELECSYS HIV DUO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code MZF·January 26, 2026

    ANN BLUNT TIP SCREW 4X36MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·June 6, 2024

    VISUALASE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code GEX·August 28, 2024

    COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·August 29, 2017

    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·July 10, 2017

    PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·June 6, 2024

    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

    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 20, 2016