BEUDAMED
    17 results · 34ms · 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 ×

    ELEC-LED

    FDA 510(k)
    FDA Class 1 ·Dental

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049958001383·Medilas D MultiBeam Diode Laser, Green Pilot Be...

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049958000225·Medilas D MultiBeam Diode Laser, D-Plug

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707036517·EDGEWISE DB BRACKET 22 BH KIT

    AUTOALIGN

    FDA 510(k)
    FDA Class 2 ·Radiology

    NAVIAID ICVI DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·October 29, 2002

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 27, 2014

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·July 29, 2011

    UV FLASH TRANSFER SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 2, 2013

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·March 1, 2018

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·January 6, 2021

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·January 6, 2021

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·October 27, 2014

    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

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021