BEUDAMED
    9 results · 19ms · 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 ×

    Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

    FDA 510(k)
    FDA Class 1 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 25, 2022

    BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code LQC·August 25, 2011

    UNKNOWN ZIMMER TM REVERSE SHOULDER

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code HSD·October 29, 2014

    ONE-THIRD TUBULAR PLATE 4 HOLES/49MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018