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

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    Multi-Parameter Patient Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383514903·"An absorbent paper points is an endodontic pap...

    MODIFIED CONCENTRIC MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

    INTEGRIP CC, CLUSTER 54MM, G2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·September 24, 2024

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·September 27, 2023

    BD 1ML SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 26, 2019

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 2013

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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.·August 5, 2015

    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