BEUDAMED
    13 results · 18ms · Sources: EU EUDAMED, US FDA

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    I.V. PLASTIC BAG

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780811·LEVAMED ACTIVE ANKLE SUP SLVR R III

    ERA Std. Ovd. Impression Coping

    FDA UDI
    STERNGOLD DENTAL LLC·00841549116285·Records and transfers implant position to a wor...

    AURADONICS

    FDA UDI
    AURADONICS INC.·00810033836756·LATEX ELASTICS 5/16" 2.5 oz. - NEON, 100000 ea....

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112330·Tap, 5.50mm, Fixed Sleeve

    BD EMERALD 2ML SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 17, 2020

    SUPRIS RETROPUBIC SLING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CONSULTA CRT-D

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

    MICRO CURVED ATTACHMENT

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

    PY PACING LEAD

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DTB·August 11, 2010

    CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 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