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

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    PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040

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

    AUTOSTAT II ENA-4 PROFILE ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIOCUFF,C, MODELS 236018, 236028, 236036

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STEM EXTENSION

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·March 29, 2023

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 11, 2024

    STEMMED NONAUGMENTABLE TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·June 9, 2023

    LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 9, 2022

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 21, 2011

    RIATA PASSIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012