BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    QUALITY REPORTS

    FDA 510(k)
    FDA Class 2 ·Radiology

    EBERLE

    FDA UDI
    Eberle GmbH & Co. KG·04050052020125·Aggressive Meniscus Cutter Plus 4,2

    PEAN INSTESTINAL FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896024083·PEAN INSTESTINAL FORCEPS CURVED TIP LONGITUDNAL...

    CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·December 27, 2019

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·February 16, 2024

    ARCHITECT C8000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·March 15, 2019

    ALIGN URETHRAL SUPPORT SYSTEM RETROPUBIC

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·May 29, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 4, 2014

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·May 26, 2011

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·September 7, 2018

    ARCHITECT C16000

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·October 14, 2020

    OT VERIO FLEX METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE GMBH·Product code NBW·February 9, 2022

    OT VERIO FLEX METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE GMBH·Product code NBW·February 9, 2022

    MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019

    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