BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    ALCON SURGICAL SPONGE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707035848·WEB I MOL BANDS G8421-16+G2820-00 LR 4

    RAPIDEC STAPH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    EMPI, MODEL 489, TENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA UDI
    Zimmer, Inc.·00889024143661·

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·October 6, 2020

    SYMBIQ SCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 15, 2014

    HEARTMATE II LVAS, EUROPE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·January 2, 2013

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010

    30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10; Spinning Spiros Closed Male Luer, Red Cap, REF: CH2000S-C; Spiros, Closed Male Luer w/Red Cap, 10 Units, RES: CH2000SC-10; Spiros, Closed Male Luer w/Red Cap, 5 Units, REF: CH2000SC-5; Spinning Spiros Closed Male Luer, Purple Cap, REF: CH2000S-PC; Conector macho cerrado Spinning Spiros, tapon purpura, REF: 034-CH2000S-PC; Spiros, Purple Cap, Drop-In Priming Cap, REF: CH2000S-PCP; Spinning Spiros Closed Male Luer w/Red Cap, REF: CH3515; Spinning Spiros Closed Male Luer, REF: Z7072

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 30, 2020

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017