BEUDAMED
    18 results · 21ms · 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 ×

    ChoiceSpine Tiger Shark Cervical Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CODMAN

    FDA UDI
    Cerenovus, Inc.·10886704001423·CODMAN SLIM-LINE Aneurysm Clip Sideward Angled ...

    NA

    FDA UDI
    Synthes GmbH·10886982142214·2.4MM CORTEX SCREW SELF-TAPPING 13MM

    10M - Southwest Gas Corp

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588010434·10M - Southwest Gas Corp

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 14, 2011

    VARIS 1.4G

    FDA 510(k)
    FDA Class 2 ·Radiology

    HA ORBITAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2022

    GE OEC 9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008

    XPOSE 4 DEVICE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR·Product code DXC·August 4, 2011

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 9, 2021

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 8, 2011

    CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·April 10, 2024

    DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)

    FDA Enforcement
    Class II ·Terminated·Canon Medical System, USA, INC.·September 12, 2018

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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

    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