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

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    AHL GENERIC GLASS IONOMER LUTING CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    IVENT 201 PORTABLE VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INION CPS 2.5/2.8 SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code HWC·September 23, 2015

    TRIATHLON PS X3 TIBIAL INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·March 27, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 10, 2011

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008

    APPLIANCE, FIXATION, NAIL

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KTT·August 18, 2015

    UNKNOWN HEAD

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·April 26, 2017

    ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LZO·April 26, 2017

    APPLIANCE,FIXATION,NAIL

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code KTT·October 10, 2016

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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