BEUDAMED
    15 results · 28ms · 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.

    BRAIN HEART INFUSION

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TEE Kit

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436108362·Rail Adapter and TEE Transducer Holder

    AURADONICS

    FDA UDI
    AURADONICS INC.·00810033835629·EXTRAORAL LATEX ELASTICS 1/4" 8 oz. - AMBER, 10...

    ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PICCOLO COMPOSITE NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 24, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2015

    INSERTER FOR TI ELASTIC NAILS

    FDA Adverse Event
    Malfunction ·SYNTHES RARON·Product code LXH·November 2, 2016

    2.5MM TI ELASTIC NAIL 440MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HTY·April 28, 2015

    INSERTER FOR TI ELASTIC NAILS

    FDA Adverse Event
    Malfunction ·SYNTHES RARON·Product code LXH·April 28, 2015

    Inserter for Titanium Elastic Nails (TEN), orthopedic device

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·October 21, 2015

    Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 18, 2015

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024