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

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    Penumbra System (Reperfusion Catheter RED 62)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113646·RETROBULBAR NEEDLE 23GA 38MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114216·LASIK CANNULA FLATTENED 23GA

    SOFTLASE - SURGICAL DIODE LASER SYSTEM

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

    PHILIPS DIGITAL IMAGING OPTION RELEASE 1

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2024

    GALILEO NEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·September 21, 2012

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN-BENNETT CORP.·Product code CBK·October 15, 2008

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·July 2, 2013

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    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 Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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