BEUDAMED
    17 results · 22ms · 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 ×

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827936·ACHIMED ACHILLES SUPP BLACK V

    JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040160425·Channels Flex Assorted Pack 21mm .04 Taperx....

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717106873·Paper Points, Taper .04, Size #45, 100pcs/box

    5 x 15mm CitreLock Implant

    FDA UDI
    Acuitive Technologies, Inc.·00810027270207·

    NA

    FDA UDI
    STRYKER CORPORATION·07613153001027·6.0mm Round Fluted Carbide Bur Extra Long

    PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDLOGICS ML 4000, MODEL 4000

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    GLIDESCOPE TITANIUM SMART CABLE

    FDA Adverse Event
    Malfunction ·VERATHON MEDICAL ULC·Product code CCW·May 5, 2016

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 30, 2009

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    TOTAL ASR ACET IMP SIZE 48

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·March 26, 2013

    UNITRAX C-TAPER SLEEVE +10MM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code KWL·February 16, 2011

    9617604-2008-00026

    FDA Adverse Event
    Malfunction ·Product code JKA·February 29, 2008

    HOMEPUMP C-SERIES 270ML, 5ML/HR

    FDA Adverse Event
    Malfunction ·HALYARD - IRVINE·Product code MEB·July 22, 2015

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018