BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OSTOM-I ALERT

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    THE PL-1064 LASER SYSTEM

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

    KYPHON HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 25, 2017

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·April 7, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 19, 2020

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 4, 2019

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Injury ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 17, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·December 17, 2018

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 7, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 12, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 9, 2020

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·September 17, 2008

    UNKNOWN DEEP BRAIN STIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·June 16, 2011

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    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