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

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    PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Q-RAD System

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971031150·Q-RAD SYSTEM/QGV-40-2-R10-T600

    SPROTTE®

    FDA UDI
    Pajunk GmbH Medizintechnologie·14048223014285·SPROTTE® 22G x ...

    SPROTTE®

    FDA UDI
    Pajunk GmbH Medizintechnologie·04048223114902·Needle

    SPROTTE®

    FDA UDI
    Pajunk GmbH Medizintechnologie·04048223052945·Needle

    SWAB ALCOHOL

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code LKB·May 4, 2020

    ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VASOTRAC APM205A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, COSTA RICA LTDA·Product code OAE·March 31, 2022

    S3 EX - 3005

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 2, 2013

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 22, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·April 18, 2008

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·July 9, 2024

    Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

    FDA Enforcement
    Class II ·Ongoing·Canary Medical, Inc.·July 16, 2025

    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

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018