BEUDAMED
    15 results · 17ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE UNDERPADS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780804·LEVAMED ACTIVE ANKLE SUP SLVR R II

    ERA RV Partial Impression Coping

    FDA UDI
    STERNGOLD DENTAL LLC·00841549116278·Records and transfers implant position to a wor...

    AURADONICS

    FDA UDI
    AURADONICS INC.·00810033836749·LATEX ELASTICS 1/4" 2.5 oz. - NEON, 100000 ea.,...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112320·Tap, 4.75mm, Fixed Sleeve

    Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GAP ENDO-EXO MEDULLARY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD¿ IV SET SN404 W/O BP Y-CONN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·May 9, 2019

    CONCERTO II CRT-D

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

    7.5CM SHORT ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 11, 2013

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·August 11, 2010

    BD¿ IV SET SN404 W/O BP Y-CONN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·April 26, 2019

    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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