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

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    FREEDOM Integrated Syringe Infusion System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEBAKEY FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896084599·DEBAKEY FORCEPS MICROSCOPIC WIDE TIP ROUND HAND...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776165451·HARRINGTON RETR LAMB-HNDL .

    Ratchet Handle

    FDA UDI
    Treace Medical Concepts, Inc.·00810111222693·Ratchet Handle

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114063·MCINTYRE-BINKHORST CAN 25GA ANG RT PK/10

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780454670·Integra® Jarit® Harrington Retractor, 12-1/2", ...

    Initia Total Hip System

    FDA UDI
    KYOCERA CORPORATION·04547898307867·MXHO LINER 36-52/54

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306823336·Marina Nasal Osteotome, 4mm, 18cm

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·February 5, 2002

    HDR MIAMI APPLICATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASCENSION ANKLE FUSION PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    PROTECTA XT VR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·August 10, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 1, 2013

    CLINICAL CHEMISTRY LACTATE DEHYDROGENASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CFJ·May 5, 2017

    CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·May 17, 2017

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    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