BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Celerity Incubator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYRINGE 0.5ML 28GA 1/2IN BLS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 8, 2021

    RIBBOND - TRIAXIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    HEARTSINE SAMARITAN PAD 350P

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    VET SYRINGE 0.5ML X 29G X 12.7MM 10 BAG

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949·Product code FMF·March 2, 2024

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·August 17, 2011

    SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 5 MM TIP UNIVERSAL TEMPERATURE MONITORI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.·Product code LPB·October 30, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)

    FDA Adverse Event
    Malfunction ·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017