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

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    Powder Free Latex Examination Glove, Non-Sterile

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Richard-Allan® Needle 1/2 Circle Taper

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00840113216369·Intent to be used with suture material for tiss...

    GRYPHON

    FDA UDI
    Medos International Sàrl·10886705025527·GRYPHON HARD BONE DRILL

    Kompressor™ Compression Screw System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780280064·Kompressor™ Compression Screw System 2.5MM DRIL...

    Nex-Link®

    FDA UDI
    ZIMMER SPINE, INC.·00889024332423·

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383514729·"An absorbent paper points is an endodontic pap...

    TLC Uni Knee Femoral Implant

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215077259·

    EASYPOINT

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

    EASYPOINT

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

    ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX

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

    HERO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    UNKNOWN·Product code IKX·October 29, 2014

    UNICEL DXC 800 SYNCHRON SYSTEM

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

    ACUITY

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

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 12, 2016

    GRYPHON HARD BONE DRILL

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HWE·September 5, 2019

    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 S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025